Diphenhydramine HCL

Product NDC: 71205-615
11-digit product format: 712050615
Labeler code: 71205
Product ID: 71205-615_49763843-7dc9-4416-a2c8-c49f84337322
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCL
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-01-27
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: 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	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
5943d975-77e4-4cbd-b2d9-d699052fe82a	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
71205-615-20	Diphenhydramine HCL	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	3
71205-615-30	Diphenhydramine HCL	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	3
71205-615-60	Diphenhydramine HCL	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	3
71205-615-90	Diphenhydramine HCL	90 in 1 BOTTLE, PLASTIC	CAPSULE	90	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-615	DIPHENHYDRAMINE HCL CAPSULE [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 4 package rows	20240112_5943d975-77e4-4cbd-b2d9-d699052fe82a.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 150 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tukol Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	27ab3d86-e960-4d83-aad1-d50d2c8e02a9	2024-10-14	Warnings	Exact identifier application number: M012
HealthWise Chest Rub Lavender	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Veridian Healthcare	2472ce85-c701-4fcd-e063-6394a90a2765	2024-10-14	Warnings	Exact identifier application number: M012
HealthWise Chest Rub Lemon	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Veridian Healthcare	24740d5a-aba1-0bd4-e063-6394a90ab2ca	2024-10-14	Warnings	Exact identifier application number: M012
Childrens Plus Cough and Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ea059b56-dc9a-4a6b-8c16-5dfcdaf4cd43	2024-10-14	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESIN	Haleon US Holdings LLC	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	2024-10-14	Warnings	Exact identifier application number: M012
Cough Relief Adult	DEXTROMETHORPHAN HBR	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f5c57b32-69cb-469e-ad2d-64c00b5e66dc	2024-10-14	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Publix Super Markets Inc	94c21df5-c631-4748-a833-288b2298055c	2024-10-12	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	8eab9d79-69c1-44b8-9145-a7ebd887d54d	2024-10-11	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	e4963eec-fb4a-425c-be19-f514b4f10a7f	2024-10-11	Warnings	Exact identifier application number: M012
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association	1b4e87f8-3f9e-4865-9128-527d2d621593	2024-10-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	ff433512-55b7-4fc9-8a55-aff5cbb749ef	2024-10-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	3170354a-4752-49a0-97ed-3d9db266a059	2024-10-11	Warnings	Exact identifier application number: M012
Tukol Children Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	235a6d2b-7302-410c-be35-4d5ff7bbdfce	2024-10-11	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS Pharmacy	6c7b0ea6-bff9-4fd2-9e00-64015c326ee8	2024-10-11	Warnings	Exact identifier application number: M012
nitetime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Meijer Distribution Inc	dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b	2024-10-11	Warnings	Exact identifier application number: M012
Signature Care Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	838d2f11-2ee4-4081-98c8-b87e79aa47c4	2024-10-11	Warnings	Exact identifier application number: M012
Menthol	COUGH SUPPRESSANT	McKesson	9d4def70-480f-f2fa-e053-2995a90a9877	2024-10-10	Warnings	Exact identifier application number: M012
Menthol	COUGH SUPPRESSANT	McKesson	9d5b4ef6-4eb8-41f6-e053-2a95a90a1350	2024-10-10	Warnings	Exact identifier application number: M012
Tukol Sugar Free Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Genomma Lab USA	95e0a3eb-5a58-4c8b-a70b-fb0cca1e0841	2024-10-08	Warnings	Exact identifier application number: M012
Rompe Pecho CF CF	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Efficient Laboratories Inc	06e96e0c-f21f-e706-e063-6294a90a0780	2024-10-08	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	5943d975-77e4-4cbd-b2d9-d699052fe82a	3
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	5943d975-77e4-4cbd-b2d9-d699052fe82a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-615-20	71205061520	20 CAPSULE in 1 BOTTLE, PLASTIC (71205-615-20)	20 capsule	2024-01-02		No	No	Current
71205-615-30	71205061530	30 CAPSULE in 1 BOTTLE, PLASTIC (71205-615-30)	30 capsule	2021-10-20	0000-00-00	No	No	Current
71205-615-60	71205061560	60 CAPSULE in 1 BOTTLE, PLASTIC (71205-615-60)	60 capsule	2021-10-20	0000-00-00	No	No	Current
71205-615-90	71205061590	90 CAPSULE in 1 BOTTLE, PLASTIC (71205-615-90)	90 capsule	2021-10-20	0000-00-00	No	No	Current