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 3 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dollar General	NASAL PHENYLEPHRINE HYDROCHLORIDE	DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)	e8fd3f0e-a023-4423-8906-17ae02bc083b	2026-09-03	Warnings	Exact identifier application number: M012
Mucus Relief Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	TARGET Corporation	1bf9a59e-cc37-4780-ba75-7138c546eb19	2026-09-02	Warnings	Exact identifier application number: M012
Childrens Multi Symptom Fever and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	THE KROGER CO.	3daf7620-eb57-43d5-ba88-938b7221e346	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Gil Pharmaceutical Corp	69fd13a1-2b76-8574-e053-2a91aa0a27e7	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Gil Pharmaceutical Corp.	a6880389-0dc1-43a7-a73b-77f77bafe51e	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Gil Pharmaceutical Corp	fa8510d8-d50a-4743-ba87-a12e9ab43125	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	dfcf1231-8271-458d-b375-e328d6fd4e9b	2026-09-02	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Shield Pharmaceuticals Corp	decafa3a-3734-4161-bab0-121945881846	2026-09-02	Warnings	Exact identifier application number: M012
Kroger Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL	KROGER COMPANY	1ff037ea-1a3b-430a-be31-2e240cc3b6f3	2026-09-02	Warnings	Exact identifier application number: M012
KROGER Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	KROGER COMPANY	79d24014-1af7-4d62-bcb8-5bea76a7d6ee	2026-09-02	Warnings	Exact identifier application number: M012
Kroger No Drip	ALLERGY SINUS	KROGER COMPANY	4788bafb-8866-4a0a-b217-226513799c24	2026-09-02	Warnings	Exact identifier application number: M012
Maximum Strength Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	KROGER COMPANY	e1d27123-358f-4b0c-8e3b-33474750a0e6	2026-09-02	Warnings	Exact identifier application number: M012
Maximum Strength Nighttime Cold and Flu	ACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCL	THE KROGER CO	058b2021-8a61-40b0-8a2e-a784d2b847fb	2026-09-02	Warnings	Exact identifier application number: M012
KROGER Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2bea22e9-34b6-4961-94bb-5600dd90e891	2026-09-02	Warnings	Exact identifier application number: M012
KROGER No Drip Nasal Mist Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	KROGER COMPANY	7256e048-ad69-4322-844d-872f05e6fc8a	2026-09-02	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	The Kroger Co.	494e69ef-dc9f-4e14-b856-5eaf0f541a03	2026-09-02	Warnings	Exact identifier application number: M012
MAX Tussin Cough and Chest Congestion DM Sugar Free	DEXTROMETHORPHAN HBR, GUAIFENESIN	Akron Pharma Inc.	5c4c8115-cec9-4f2c-9ea9-328535e97b07	2026-09-01	Warnings	Exact identifier application number: M012
MAX ALLERGY KIDS	DIPHENHYDRAMINE HCL	Akron Pharma Inc.	96c4ade8-67b1-41e5-8624-fb49090208af	2026-09-01	Warnings	Exact identifier application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE	HEXYLRESORCINOL AND MENTHOL	Reckitt Benckiser LLC	4a938e15-a996-8538-e063-6294a90ad4ee	2026-09-01	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	WALMART INC.	5e6623c3-6210-4c50-94d6-5554f36876d1	2026-08-31	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