DIPHENHYDRAMINE HYDROCHLORIDE

Product NDC: 53345-007
11-digit product format: 533450007
Labeler code: 53345
Product ID: 53345-007_2767a338-d7e3-dc51-e063-6394a90a29b2
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-09-15
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
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
9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6	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
53345-007-01	DIPHENHYDRAMINE HYDROCHLORIDE	20000 in 1 BAG	CAPSULE, LIQUID FILLED	20000		4
53345-007-01	DIPHENHYDRAMINE HYDROCHLORIDE	1 in 1 BOX	CAPSULE, LIQUID FILLED	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53345-007	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	4	Current NDC, Legacy NDC, 2 package rows	20241122_9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6.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 175 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Multi-Symptom Mapap Cold Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Proficient Rx LP	9bf81b26-38b4-486c-ae89-222119ce1a4f	2023-11-01	Warnings	Exact identifier application number: M012
Guaifenesin Syrup and Dextromethorphan	GUAIFENESIN SYRUP AND DEXTROMETHORPHAN	Natco Pharma USA LLC	ad9026f4-f0b6-4d02-aa44-f0460eeefc0e	2023-11-01	Warnings	Exact identifier application number: M012
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HYDROCHLORIDE	Natco Pharma USA LLC	54b64354-ac10-42ff-a53d-96cef933a91a	2023-11-01	Warnings	Exact identifier application number: M012
children allergy relief dye free cherry	DIPHENHYDRAMINE HCL	A-S Medication Solutions	5c6c1809-4c6f-4e8f-a5ae-9796e821d400	2023-11-01	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0903b222-1a44-64aa-e063-6294a90abba0	2023-10-31	Warnings	Exact identifier application number: M012
Ephrine Nose Drops	PHENYLEPHRINE HYDROCHLORIDE	Walgreens	b620eb9f-2caf-0942-e053-2a95a90ae48e	2023-10-31	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	204849d1-ac4b-4dbe-8769-fcb30291f880	2023-10-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	DAYTIME COLD AND FLU RELIEF	TopCo Associates, LLC	d592fbb8-d4bf-444e-982e-edf6fe97dce4	2023-10-31	Warnings	Exact identifier application number: M012
Nite Time Cold and Flu Relief	NITE TIME COLD AND FLU RELIEF	TopCo Associates, LLC	407dc4ae-882d-4a49-8884-ef048bb404cf	2023-10-31	Warnings	Exact identifier application number: M012
12 Hour Original Nasal Decongestant	NASAL SPRAY	Sheffield Pharmaceuticals LLC	cea0ce76-ae75-4484-a7c2-ff1086e9d8b0	2023-10-30	Warnings	Exact identifier application number: M012
Mucosa DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Magno-Humphries, Inc.	3a5533fb-1c83-4b95-9cd2-9be663d3ff5f	2023-10-27	Warnings	Exact identifier application number: M012
Mucosa Guifenesin	GUAIFENESIN	Magno-Humphries, Inc.	9d22c208-d0ae-8b6a-e053-2995a90ab90a	2023-10-27	Warnings	Exact identifier application number: M012
DG Health Cough Drops Cherry Flavor	MENTHOL	Dollar General Corporation	c7a603d8-72fb-9626-e053-2995a90a09ea	2023-10-26	Warnings	Exact identifier application number: M012
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	Geri-Care Pharmaceutical Corp	92d90b41-0627-121e-e053-2995a90a2df1	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Cherry	MENTHOL	Riclan S.A.	8e471265-3594-451a-8921-f0db474abe85	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Eucalyptus	MENTHOL	Riclan S.A.	1141593a-f3ba-4adf-b332-f9fcb0b5a013	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Honey Lemon	MENTHOL	Riclan S.A.	f6271e85-9ca2-41d3-9bff-a13670ac5b80	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Strawberry	MENTHOL	Riclan S.A.	da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457	2023-10-26	Warnings	Exact identifier application number: M012
DG Health Cough Drops Assorted Flavors	MENTHOL	Dollar General Corporation	c731d255-40f2-3cb3-e053-2a95a90a8877	2023-10-26	Warnings	Exact identifier application number: M012
ALKA SELTZER PLUS Cold Day and Night Effervescent	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Sincronia Logistica, S.A. de C.V.	c478df69-823a-4112-8f44-323249a9f38f	2023-10-23	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	9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6	4
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53345-007-01	53345000701	1 BAG in 1 BOX (53345-007-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAG	1 bag	2013-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg capsule, liquid filled	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	2024-11-21	HUMAN OTC DRUG LABEL	4