Diphenhydramine Hydrochloride

Product NDC: 68094-018
11-digit product format: 680940018
Labeler code: 68094
Product ID: 68094-018_315b150d-b34d-422c-b3c4-287dd908df8f
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Precision Dose, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-07-15
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: Diphenhydramine Hydrochloride
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
4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4	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	Strength	SPL version
68094-018-59	Diphenhydramine Hydrochloride	10 in 1 BLISTER PACK	TABLET	10		5
68094-018-61	Diphenhydramine Hydrochloride	10 in 1 CARTON	TABLET	10		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-018-59	EA - Each	68094-018	64535cc0-28a9-4b6d-baa9-5b6541cc7fa5	1	2019-08-06
68094-018-61	EA - Each	68094-018	76194eaa-6c1c-4f96-b3c0-3cdd75a28764	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68094-018	DIPHENHYDRAMINE HYDROCHLORIDE TABLET [PRECISION DOSE, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20250309_4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4.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 154 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topcare Nasal Decongestant Maximum Strength Non Drowsy	PSEUDOEPHEDRINE HCL	Topco Associates LLC	1a9e0336-c0c2-43f8-aeea-668d4a209714	2024-09-20	Warnings	Exact identifier application number: M012
Leader Nasal Decongestant	PSEUDOEPHEDRINE HCL	Cardinal Health 110, LLC. dba Leader	25609b66-047c-46e7-bc95-20eb8e6c9617	2024-09-20	Warnings	Exact identifier application number: M012
equaline nasal	PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	67fdd277-7a7a-4404-8ca2-39802c46405f	2024-09-20	Warnings	Exact identifier application number: M012
equaline tussin	DEXTROMETHORPHAN HBR, GUAIFENESIN	United Natural Foods, Inc. dba UNFI	8bc7fa7c-d565-48c9-9808-1042c3e9d428	2024-09-20	Warnings	Exact identifier application number: M012
Leader Adult Tussin Mucus and Chest Congestion 541	GUAIFENESIN	CARDINAL HEALTH 110, LLC. DBA LEADER	d7fae410-9c1c-4231-9fde-2c51ad3d7e95	2024-09-20	Warnings	Exact identifier application number: M012
sinus	PSEUDOEPHEDRINE HYDROCHLORIDE	Kroger Company	18812f2a-9b66-45a7-9631-123da6fd1c1f	2024-09-20	Warnings	Exact identifier application number: M012
Good Sense Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	930469c1-384c-4440-b3e6-9dcd674871c4	2024-09-19	Warnings	Exact identifier application number: M012
Cold and Flu Relief Multi Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WinCo Foods, LLC	89272d2d-5533-4ae8-865b-cb204cec6d65	2024-09-17	Warnings	Exact identifier application number: M012
Cold and Flu Relief Multi Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WinCo Foods, LLC	5791c1c7-f614-4940-a45a-6291742e1e22	2024-09-17	Warnings	Exact identifier application number: M012
nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	2affd44d-2125-4a1f-919c-c082e7644ea8	2024-09-17	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE	Advanced Rx LLC	fa1a4d86-87bb-0c50-e053-6394a90a56e2	2024-09-13	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Advanced Rx LLC	fa1b60b1-49cb-1211-e053-6394a90a0a46	2024-09-13	Warnings	Exact identifier application number: M012
nasal	PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	8db7df1c-46b5-49bd-9002-50b12d58001a	2024-09-13	Warnings	Exact identifier application number: M012
meijer Daytime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	1bdd7f8a-93ce-5309-e063-6294a90a91f0	2024-09-12	Warnings	Exact identifier application number: M012
oxymetazoline hcl	OXYMETAZOLINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	a1103cd8-344b-4a65-8a60-3c7be86d01a6	2024-09-11	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	L. Perrigo Company	276d7d3c-c4a7-4754-8845-c38f85aac5f7	2024-09-08	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Strategic Sourcing Services LLC	4ff5a4ae-9649-4a6d-a5f8-ca23efbbb479	2024-09-08	Warnings	Exact identifier application number: M012
equate nasal original	OXYMETAZOLINE HYDROCHLORIDE	Wal-Mart Stores Inc	7e40c9b8-e0b5-448a-a674-72388fbab189	2024-09-08	Warnings	Exact identifier application number: M012
Anefrin Nasal Original	OXYMETAZOLINE HYDROCHLORIDE	Walgreen Company	85b442dc-1703-4fef-948a-fad7cbe9f224	2024-09-07	Warnings	Exact identifier application number: M012
equaline nasal	OXYMETAZOLINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	07e0328e-1912-4f25-9e1e-9482d4665be0	2024-09-07	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	4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4	5
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68094-018-59	68094001859	10 in 1 BLISTER PACK						Historical
68094-018-61	68094001861	10 BLISTER PACK in 1 CARTON (68094-018-61) / 10 TABLET in 1 BLISTER PACK (68094-018-59)	10 blister pack	2019-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenhydramine Hydrochloride	Cardinal Health 107, LLC	2026-08-07	HUMAN OTC DRUG LABEL	1
Diphenhydramine Hydrochloride	Precision Dose, Inc.	2025-09-12	HUMAN OTC DRUG LABEL	5