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 47 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive daytime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	51e34704-5e6b-4e80-836c-ddbc24a451b2	2026-03-06	Warnings	Exact identifier application number: M012
Medi-First Plus Sinus Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	20f58b0b-c123-477f-a62c-fa5423e23f93	2026-03-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength	PHENYLEPHRINE HCL	Sportpharm LLC	7f4e8d37-8c6b-4849-b86c-4335a0bcac1c	2026-03-06	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cold and Flu Kit	DAYTIME AND NIGHTTIME COLD AND FLU KIT	Allegiant Health	0533db78-7809-46ea-9998-deb5f6f1d0d9	2026-03-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	Better Living Brands, LLC	0153294d-7f52-4d92-8db8-daeca3e29a3b	2026-03-06	Warnings	Exact identifier application number: M012
Mucus DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Meijer Distribution, Inc.	87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e	2026-03-06	Warnings	Exact identifier application number: M012
RYNEX PE	BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	EDWARDS PHARMACEUTICALS, INC.	77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef	2026-03-05	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Best Choice (Valu Merchandisers Company)	042f9449-4af0-4b15-bb3e-236afeb1e11f	2026-03-05	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN	Amerisource Bergen	087a3a0b-8d3f-45ed-8807-0af47b446cac	2026-03-05	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG	NUVICARE LLC	6c4bc7d1-09d9-4311-8457-a1d47ab02a5a	2026-03-05	Warnings	Exact identifier application number: M012
Allergy Relief childrens	DIPHENHYDRAMINE HCL	WALMART INC.	dceb99a9-4aa3-4acc-b632-9a4ba8c87919	2026-03-04	Warnings	Exact identifier application number: M012
AMAZON Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AMAZON.COM SERVICES LLC	26101105-a6cf-4b51-a639-9d078542fea3	2026-03-04	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	Major Pharmaceuticals	3a976e90-c6af-4414-984e-9987158c9e98	2026-03-04	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Best Choice (Valu Merchandisers Company)	714e93ec-0aa9-4be2-9311-399e82f148e0	2026-03-04	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	d1131759-dd2e-4c06-bb73-92dd975f5511	2026-03-04	Warnings	Exact identifier application number: M012
AMAZON Maximim Strength Adult Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	AMAZON.COM SERVICES LLC	6bbe8cc9-7a60-4476-b5cf-b13c5bebff26	2026-03-04	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	5a1dfaf3-370d-4ac7-a72d-a48863a35741	2026-03-04	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Walgreen Company	c5cb09d4-c049-461c-8898-2c5bb6a8a138	2026-03-04	Warnings	Exact identifier application number: M012
Tussin CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	WinCo Foods, LLC	3d96d6d0-8c04-43bb-aed0-4cd00cdf3456	2026-03-04	Warnings	Exact identifier application number: M012
DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	e2994c0f-add8-4f75-a6d2-24cd2af271e4	2026-03-03	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