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 69 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate Menthol Chewable Gels	MENTHOL	Walmart	1ba4b2be-7242-0a23-e063-6294a90af29c	2025-12-23	Warnings	Exact identifier application number: M012
Walgreens Severe Menthol Throat Drops	MENTHOL	Walgreens	21dd3c68-cbc6-4799-e063-6394a90a6972	2025-12-23	Warnings	Exact identifier application number: M012
cherry throat relief lozenges	BENZOCAINE	Zee Medical	499d0748-538f-678c-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
Guaiasorb DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	NuCare Pharmaceuticals, Inc.	46a480c7-7092-b809-e063-6294a90a60cd	2025-12-23	Warnings	Exact identifier application number: M012
menthol cough drops	MENTHOL	Winco Foods	360a6304-206d-5475-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
menthol cough drops	MENTHOL	Winco Foods	36342d8c-34ab-6178-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
cherry cough drops	MENTHOL	Winco Foods	37244333-1307-5121-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Winco foods	37718c73-880e-4a5c-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Winco Foods	40676ddc-577f-5cc9-e054-00144ff88e88	2025-12-23	Warnings	Exact identifier application number: M012
Sugar Free Menthol Cough Drops	MENTHOL	Winco Foods	3788e8b6-ab9e-1513-e054-00144ff88e88	2025-12-23	Warnings	Exact identifier application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	KRAMER LABORATORIES	eeca6370-29ea-4540-8139-e8461d58a286	2025-12-23	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Discount Drug Mart	dd31f86b-f59e-459a-8e5f-176828706a4a	2025-12-23	Warnings	Exact identifier application number: M012
Tussin CF	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Discount Drug Mart	f8e7a08e-7422-4a1b-bfec-93e0b50d10cd	2025-12-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	ab45ae97-7951-4058-e053-2995a90a7b2e	2025-12-23	Warnings	Exact identifier application number: M012
Childrens Chest Congestion Relief Grape	GUAIFENESIN	Discount Drug Mart	3e5d245f-515c-4106-a855-fb97681b646a	2025-12-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	ab45ed16-86bb-3faf-e053-2995a90acfbc	2025-12-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	a7999da7-148a-4c6d-a2ea-0f4cc1d5b283	2025-12-23	Warnings	Exact identifier application number: M012
Safetussin High Blood Pressure and diabetes Cough, Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	KRAMER LABORATORIES	279e309c-040d-4001-808d-b7d986a9a1d8	2025-12-23	Warnings	Exact identifier application number: M012
Sinus PE Head Congestion and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	76fd1f8e-2670-421c-a9e6-c8adefb7962e	2025-12-23	Warnings	Exact identifier application number: M012
Leader Cough Drops Vanilla Honey	MENTHOL	Cardinal Health 110, LLC. DBA Leader	1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e2	2025-12-22	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