Allergy

Product NDC: 53943-090
11-digit product format: 539430090
Labeler code: 53943
Product ID: 53943-090_249d8323-64cc-0a0a-e063-6394a90a1d70
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Discount Drug Mart
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-11-30
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Allergy
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049630	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4f42c8d2-0538-4bcd-aac0-e26103a30499	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53943-090-01	Allergy	12 in 1 BLISTER PACK	TABLET, COATED	12	4
53943-090-01	Allergy	2 in 1 CARTON	TABLET, COATED	2	4
53943-090-03	Allergy	100 in 1 BOTTLE	TABLET, COATED	100	4
53943-090-03	Allergy	1 in 1 CARTON	TABLET, COATED	1	4
53943-090-05	Allergy	400 in 1 BOTTLE, PLASTIC	TABLET, COATED	400	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-090	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [DISCOUNT DRUG MART]	4	Current NDC, Legacy NDC, 5 package rows	20241018_4f42c8d2-0538-4bcd-aac0-e26103a30499.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 46 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime and Nighttime	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS HEALTH CORP	43da4211-3bb3-0a8e-e063-6294a90a4fcd	2026-03-16	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	HyVee Inc	96d8b6d1-8a51-41a4-80d3-fab61492b3cc	2026-03-14	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH COLD AND FLU	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy, Inc	c0b36e4d-3667-58f6-e053-2a95a90afad7	2026-03-14	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	HyVee Inc	a16a85c2-e1fd-4d1a-a650-271ae430eb4f	2026-03-14	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Kroger Company	ab12c975-2085-4365-9c4b-0be573a260c4	2026-03-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	db0f0164-3cbd-49b0-91ef-2e5218b09c3f	2026-03-12	Warnings	Exact identifier application number: M012
Allergy Relief Complete	DIPHENHYDRAMINE HCL	WinCo Foods, LLC	88e3e51a-c9a5-43f9-b9d7-97509c607df1	2026-03-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Kickstart Severe Cold and Flu and Mucinex Fast-Max Recharge Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, AND TRIPROLIDINE HCL	RB Health (US) LLC	4cc490a6-a27a-a25b-e063-6294a90a3a95	2026-03-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOPCO ASSOCIATES LLC	6207ef50-4f28-4dbc-9a52-f44dd53d2a4f	2026-03-11	Warnings	Exact identifier application number: M012
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	c17a10a3-6b8f-4734-8f00-1f4c5c729725	2026-03-11	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	ba6d69ff-b392-4f21-b3d7-00d8ec5dee32	2026-03-11	Warnings	Exact identifier application number: M012
Sudafed PE Sinus Pressure Plus Pain	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	67428f4b-28be-4682-a9a9-781bf85089ff	2026-03-10	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	HEB	40091b98-b4c7-4a3b-e063-6294a90abd5d	2026-03-10	Warnings	Exact identifier application number: M012
Allergy	CHLORPHENIRAMINE MALEATE	United Natural Foods, Inc. dba UNFI	0aa4ac07-bd02-46b2-9cf0-0643e0e1a2da	2026-03-10	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Topco Associates, LLC	35305aa9-4fc1-4cda-b6f0-89df64f9eeff	2026-03-10	Warnings	Exact identifier application number: M012
nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	03332596-2c37-4771-b13b-ab766e616866	2026-03-10	Warnings	Exact identifier application number: M012
Sinus Pressure and Congestion Relief Maximum Strength	PSEUDOEPHEDRINE HCL	Rite Aid Corporation	d86140ab-1117-4d14-a380-f5cc375775a1	2026-03-10	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	4c9cca86-41bf-1635-e063-6294a90a17fb	2026-03-09	Warnings	Exact identifier application number: M012
sinus pressure and pain and cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Target Corporation	488588f3-62d3-4248-937a-1c200792b5f1	2026-03-09	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Grocery Outlet, Inc.	447a8753-96bd-676a-e063-6394a90a48f2	2026-03-06	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	4f42c8d2-0538-4bcd-aac0-e26103a30499	4
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	4f42c8d2-0538-4bcd-aac0-e26103a30499	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53943-090-01	53943009001	2 BLISTER PACK in 1 CARTON (53943-090-01) / 12 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2007-11-30	0000-00-00	No	No	Current
53943-090-03	53943009003	1 BOTTLE in 1 CARTON (53943-090-03) / 100 TABLET, COATED in 1 BOTTLE	1 bottle	2007-11-30	0000-00-00	No	No	Current
53943-090-05	53943009005	400 TABLET, COATED in 1 BOTTLE, PLASTIC (53943-090-05)		2016-09-30	0000-00-00	No	No	Current