Diphenhydramine Hydrochloride

Product NDC: 72789-317
11-digit product format: 727890317
Labeler code: 72789
Product ID: 72789-317_56d551ca-b3ee-5d72-e063-6294a90af6c8
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-04-14
Marketing end: 2028-04-30
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
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 Hydrochloride

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
1049909	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
879a7804-f3d4-4a3d-bc92-b473499d6c95	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
72789-317-10	Diphenhydramine Hydrochloride	10 in 1 BOTTLE, PLASTIC	CAPSULE	10	6
72789-317-12	Diphenhydramine Hydrochloride	12 in 1 BOTTLE, PLASTIC	CAPSULE	12	6
72789-317-15	Diphenhydramine Hydrochloride	15 in 1 BOTTLE, PLASTIC	CAPSULE	15	6
72789-317-20	Diphenhydramine Hydrochloride	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	6
72789-317-30	Diphenhydramine Hydrochloride	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-317-10	EA - Each	72789-317	f73d9a2f-5d75-44a8-9b88-a6002474c00f	1	2023-06-06
72789-317-12	EA - Each	72789-317	2464e553-8f01-4953-a4b5-43e849652c09	1	2023-06-06
72789-317-15	EA - Each	72789-317	43a8de8b-5675-4f49-905b-f4b4f9b2e1fe	1	2023-06-06
72789-317-20	EA - Each	72789-317	d8399382-8242-44a4-b03d-72fef2afcbc7	1	2023-06-06
72789-317-30	EA - Each	72789-317	f3bbd72e-fe79-4c59-a9b9-412ef69161a0	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-317	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	5	Current NDC, 5 package rows	20250221_879a7804-f3d4-4a3d-bc92-b473499d6c95.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 35 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	047102c4-3d03-4b2d-961d-0ac75980147b	2026-05-06	Warnings	Exact identifier application number: M012
GOOD SENSE COMBO PACK DAYTIME AND NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	d25f2649-4f8a-4339-8443-faa0b98bdd70	2026-05-06	Warnings	Exact identifier application number: M012
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	WinCo Foods, LLC	27e911e1-6d22-4a50-8413-1809c8973cbd	2026-05-06	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Cough Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51173330-d537-fb9c-e063-6394a90ae342	2026-05-05	Warnings	Exact identifier application number: M012
Equate daytime severe vaporice cold and flu nighttime severe vapor ice cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	08e74a8d-8e8d-4cda-9adc-ea2ff4068353	2026-05-05	Warnings	Exact identifier application number: M012
GOODSENSE COMBO PACK DAYTIME AND NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	L. Perrigo Company	e42f9e0d-f990-4c33-af43-75acf5d77638	2026-05-05	Warnings	Exact identifier application number: M012
Rugby Mucus and Chest Congestion 541	GUAIFENESIN	Rugby Laboratories	76472912-b66f-4bb4-937a-4a589683a78c	2026-05-04	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Daytime Non-Drowsy	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	H E B	e9dd2d7b-0a19-4a42-b51e-b9914f02406e	2026-05-04	Warnings	Exact identifier application number: M012
Sanatos Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Pharmadel LLC	3dd3ed85-0c0a-8390-e063-6294a90a668e	2026-05-04	Warnings	Exact identifier application number: M012
Good Sense Daytime non drowsy cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L. Perrigo Company	0122cd34-5817-4af5-a51a-8d176dee0a30	2026-05-04	Warnings	Exact identifier application number: M012
COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Safeway	d810a6a9-6112-4e9d-a396-36084b7e110e	2026-05-04	Warnings	Exact identifier application number: M012
Benadryl Allergy Ultratab	DIPHENHYDRAMINE HYDROCHLORIDE	Savings Distributors LLC	8d59d121-62a8-c43b-e053-2a95a90a5847	2026-05-01	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Savings Distributors LLC	8e87f8de-f83e-0f8d-e053-2a95a90a8d6a	2026-05-01	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Savings Distributors LLC	8eecb3f0-eb5e-e847-e053-2995a90a86bd	2026-05-01	Warnings	Exact identifier application number: M012
Sinus Pressure and Congestion Relief PE Maximum Strength	PHENYLEPHRINE HCL	Rite Aid Corporation	fccea3c5-42af-4939-82bc-d9409b75f91f	2026-05-01	Warnings	Exact identifier application number: M012
Night Time Cold and Flu original	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Harris Teeter, LLC	cfaf4b3d-fab4-424d-adbe-aaedca58912d	2026-04-30	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Harris Teeter, LLC	21e7d323-5b78-43aa-b0fc-34c2a864ab9a	2026-04-30	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	H E B	ec0b5f4b-b58c-445f-acf1-c7ce301bba64	2026-04-30	Warnings	Exact identifier application number: M012
Mucus Relief DM Max Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	Harris Teeter, LLC	098428ae-e87d-4c29-8f02-1590530da58e	2026-04-29	Warnings	Exact identifier application number: M012
Panadol Cold and Flu Day	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	341761b9-f0be-f816-e063-6394a90a5e63	2026-04-29	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
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	879a7804-f3d4-4a3d-bc92-b473499d6c95	6
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	879a7804-f3d4-4a3d-bc92-b473499d6c95	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-317-10	72789031710	10 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-10)	10 capsule	2023-04-05	2028-02-29	No	No	Historical
72789-317-12	72789031712	12 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-12)	12 capsule	2023-04-05	2028-02-29	No	No	Historical
72789-317-15	72789031715	15 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-15)	15 capsule	2023-04-05	2028-02-29	No	No	Historical
72789-317-20	72789031720	20 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-20)	20 capsule	2023-04-05	2028-02-29	No	No	Historical
72789-317-30	72789031730	30 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-30)	30 capsule	2023-04-05	2028-02-29	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenhydramine Hydrochloride - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2026-07-17	HUMAN OTC DRUG LABEL	7