Diphenhydramine HCl

Product NDC: 51316-221
11-digit product format: 513160221
Labeler code: 51316
Product ID: 51316-221_5c9028c4-3131-a0c1-e063-6294a90ad84c
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: CVS Pharmacy, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-01-31
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Diphenhydramine HCl
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	Strength	SPL version
51316-221-08	Diphenhydramine HCl	2 in 1 CARTON	TABLET, COATED	2		1
51316-221-08	Diphenhydramine HCl	12 in 1 BLISTER PACK	TABLET, COATED	12		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-221	DIPHENHYDRAMINE HCL TABLET, COATED [CVS PHARMACY, INC.]	1	Current NDC, 2 package rows	20240208_1059b55b-c218-843f-e063-6294a90af2fe.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 161 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	dbc71f58-0704-4d2b-aed1-0dc01f980006	2024-06-11	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	TARGET CORPORATION	135d2212-2122-b7a1-e063-6294a90aa5f5	2024-06-07	Warnings	Exact identifier application number: M012
up and up daytime honey cold flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	29da4b94-8f8e-48e8-909f-8476e3b39d78	2024-06-06	Warnings	Exact identifier application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	TARGET Corporation	e3da3003-88e3-4431-8b65-e61e17728901	2024-06-04	Warnings	Exact identifier application number: M012
Dimetapp Cold and Allergy	BROMPHENIRAMINE MALEATE	Foundation Consumer Healthcare	15c3570c-bd00-8e43-e063-6294a90a8683	2024-06-01	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Foundation Consumer Healthcare	176be362-5237-edd8-e063-6294a90a4aef	2024-06-01	Warnings	Exact identifier application number: M012
Dimetapp Nighttime Cold and Cough	DIPHENHYDRAMINE HYDROCHLORIDE	Foundation Consumer Healthcare	179115ad-d610-99b2-e063-6294a90ae711	2024-06-01	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Nighttime Cold and Cough	DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Foundation Consumer Healthcare	179259a9-231e-df03-e063-6294a90a145e	2024-06-01	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough	BROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE	Foundation Consumer Healthcare	1820e7c7-bc11-9061-e063-6394a90ae581	2024-06-01	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	682c5a4b-5ded-4276-903f-1ef1141ae518	2024-06-01	Warnings	Exact identifier application number: M012
Maximum Strength Nasal Decongestant	OXYMETAZOLINE SPRAY	CVS Health	df1f8bda-7bf3-4755-9169-f2a81d824cbe	2024-05-31	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	CVS Health	a78d29ed-019b-4014-ae6f-c60c75d19c89	2024-05-31	Warnings	Exact identifier application number: M012
Leader Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Cardinal Health 110,Inc	6594c117-6ffc-4bda-8bbf-e91c810f2c3f	2024-05-31	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	United Natural Foods, Inc. dba UNFI	1aba9b7c-8328-4a9f-8ce2-39648b2d8ae4	2024-05-23	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	fdf63308-fe7b-4613-a012-ed5e4c9f8ffe	2024-05-23	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	e61ab02d-f932-403f-a4f7-0ca354607223	2024-05-23	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	e4f9a846-ab72-4508-b0c5-f7911af2f3d7	2024-05-23	Warnings	Exact identifier application number: M012
Adult Cough Relief	DEXTROMETHORPHAN HBR	QUALITY CHOICE (Chain Drug Marketing Association)	6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c	2024-05-20	Warnings	Exact identifier application number: M012
Chlorpheniramine Maleate 4 mg	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	54681242-c861-4415-b5c0-d3ab55b62be1	2024-05-17	Warnings	Exact identifier application number: M012
Dibromm Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	c830b18b-4427-4530-9bc7-85c2735080d2	2024-05-17	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
1085945	diphenhydrAMINE HCl 50 MG Oral Tablet	PSN	1059b55b-c218-843f-e063-6294a90af2fe	1
1085945	diphenhydramine hydrochloride 50 MG Oral Tablet	SCD	1059b55b-c218-843f-e063-6294a90af2fe	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51316-221-08	51316022108	2 BLISTER PACK in 1 CARTON (51316-221-08) / 12 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2024-01-31	2028-11-30	No	No	Historical