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 49 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	97554f40-f9aa-4dbf-a6f2-de6197236ab4	2026-02-25	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Family Dollar Stores, Inc	1b50b865-3dfc-4b3f-86d5-5e91ca772445	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M012
Vaproizing	CAMPHOR	H E B	577fda09-588a-4c2e-ada5-eeda32d1aabe	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M012
Sore Throat Logenzes Sore Throat	BENZOCAINE AND MENTHOL	Major Pharmaceuticals	11416620-4892-44ba-9780-db27efff6743	2026-02-24	Warnings	Exact identifier application number: M012
Family Wellness SF Honey Lemon Cough Drops	MENTHOL	Family Dollar	4437853d-1f42-a41d-e063-6294a90aa81e	2026-02-24	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	64a93715-e7b1-4de1-8099-8ad6c585d517	2026-02-24	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Daytime	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	86af74c2-9183-4ee9-ad1e-d88dfc8bf47d	2026-02-24	Warnings	Exact identifier application number: M012
Cough DM Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	39adf23e-76f3-42e1-a9f4-55feb38078e5	2026-02-24	Warnings	Exact identifier application number: M012
Revasol Tussin DM Cough Suppressant Expectorant	DEXTROMETHORPHAN HBR, GUAIFENESIN	Rnv LLC	4b7fd320-2f39-fa1a-e063-6294a90ada9e	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Allergy	BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	47317865-4310-4f07-8815-f3130963307d	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE	Foundation Consumer Brands	42720fa0-fcdd-4614-80b2-16d0ada345b1	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	cc09a8c5-d173-4261-b838-96e6a16e2ff9	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Nighttime Cold and Congestion	DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	96a1055f-e831-4f4b-8af3-7a41838c194c	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Nighttime Cold and Congestion	DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Foundation Consumer Brands	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	2026-02-23	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Better Living Brands, LLC	0948648c-1c5f-4225-a754-120ca8859f19	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M012
Revasol Tussin	GUAIFENESIN	Rnv LLC	f66dc593-9023-40e8-9cc3-0380b04b4305	2026-02-23	Warnings	Exact identifier application number: M012
Equate Vaporizing	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Wal-Mart Stores Inc	3006971b-784c-43fd-91a6-d96876bbf185	2026-02-23	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	04e70311-6412-4a20-84e3-f6e26d5f19ab	2026-02-20	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Major Pharmaceuticals	7f2b72cc-d4f7-431f-be61-c103cf8c489e	2026-02-20	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	dca04d80-e781-40b1-e053-2995a90a7010	2026-02-20	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