Guidance for Industry
National Uniformity for Nonprescription Drugs 
Ingredient Listing for OTC Drugs
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
April 1998
Procedural Guidance #2 Guidance for Industry
National Uniformity for Nonprescription Drugs 
Ingredient Listing for OTC Drugs
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U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
April 1998
Procedural Guidance #2  GUIDANCE FOR INDUSTRY1
National Uniformity for Nonprescription Drugs 
 Ingredient Listing for OTC Drugs
I. INTRODUCTION
Section 412 of Title IV of the Food and Drug Administration Modernization Act of 1997 (the
Modernization Act), signed into law by President Clinton on November 21, 1997, amended
section 502(e) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 352(e)(1)) to
require that the established name and quantity (or, if determined to be appropriate, the
proportion) of each active ingredient appear on the label of all over-the-counter (OTC) drug
products intended for human use.  
In addition, section 502(e)(1), as amended by the Modernization Act, requires the listing of the
established name of each inactive ingredient on the outside container of the retail package and, if
determined to be appropriate by the Secretary, on the immediate container as well, as prescribed
in regulations promulgated by the Secretary.  If the drug is an OTC drug that is not a cosmetic-
drug, then the inactive ingredients must be listed in alphabetical order.  These new requirements
regarding the listing of inactive ingredients do not apply to nonprescription drugs that are not
intended for human use.
This guidance is intended to clarify the administrative processes that will be followed in
implementing these amendments to section 502(e) of the Act as they apply to OTC drug products
for human use.      
II. FDA POLICY   ACTIVE INGREDIENTS
In the Federal Register of February 27, 1997 (62 FR 9024), FDA proposed a rule that would
establish a standardized format for the labeling of OTC drug products.  The rule is intended to
make OTC drug product labeling easier to read and understand and will require the redesign of
OTC drug labels in accordance with a predetermined schedule of effective dates.  The proposed
rule includes a standardized format for listing the name and the quantity per dosage unit (or, when
appropriate, the proportion) of each active ingredient.  
1 This guidance has been prepared by the Regulations Policy Staff in the Center for Drug Evaluation and
Research (CDER) at the Food and Drug Administration (FDA).  This guidance represents the Agencys current thinking
on implementation of the Modernization Acts amendments to section 502(e)(1) for OTC drug products.  It does not
create or confer any rights for or on any person and does not operate to bind FDA or the public.  An alternative approach
may be used if such approach satisfies the requirement of the applicable statute, regulations, or both. To minimize the burden faced by manufacturers, packers, and distributors dealing with labeling
changes, FDA advises that it does not intend to object if manufacturers, packers, and distributors
choose to defer relabeling their products to comply with the new requirement to list the quantity
of OTC active ingredients until no later than the earliest applicable implementation date as
specified in the Agencys forthcoming final OTC labeling rule.
Full or abbreviated applications received after February 19, 1998, are expected to provide  labels
or labeling listing the quantity of active ingredients in compliance with the requirements of the
Modernization Act.
III.  FDA POLICY  INACTIVE INGREDIENTS
Section 502(e)(1)(iii) of the Federal Food, Drug, and Cosmetic Act, as amended by section
412(c) of the Modernization Act, states that a drug is misbranded unless its label bears "the
established name of each inactive ingredient listed in alphabetical order on the outside container of
the retail package and, if determined to be appropriate by the Secretary, on the immediate
container, as prescribed in regulations promulgated by the Secretary. . . ."
The Agency has received several letters since the signing of the Modernization Act from a trade
association representing nonprescription drug manufacturers asking whether the phrase "as
prescribed in regulations promulgated by the Secretary" modifies the entire provision, or only the
clause regarding the listing of inactive ingredients on the immediate container.
Consistent with what it believes to have been the intent of this provision, the Agency intends to
interpret both clauses  the clause for the listing of inactive ingredients on the outside container
and the clause for the listing of inactive ingredients on the immediate container  as requiring
implementing regulations before becoming effective. 
The final rule establishing a standard format for the labeling of OTC drug products based on the
proposed rule of February 27, 1997 (62 FR 9024), will provide the implementing regulations for
this requirement of the Modernization Act for OTC drug products.  The FDA will consider, as
part of that rulemaking process, whether an additional opportunity for public comment is required
for any provisions in the final rule that are intended to implement section 502(e)(iii) as amended
by the Modernization Act.
This interpretation does not revoke or supersede in any way existing regulatory and statutory
requirements governing the labeling of inactive ingredients. 
2