Antihistamine

Product NDC: 77333-231
11-digit product format: 773330231
Labeler code: 77333
Product ID: 77333-231_50fab60d-a209-cf04-e063-6294a90ab007
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: Gendose Pharmaceuticals, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-05-15
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 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: Antihistamine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 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
1020477	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
d3b2f300-d919-44cd-ab71-b74b5bdfd977	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
77333-231-10	Antihistamine	100 in 1 BOX	CAPSULE	100		1
77333-231-25	Antihistamine	1 in 1 BLISTER PACK	CAPSULE	1		1

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 167 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Robitussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Haleon US Holdings LLC	b9772292-9eb6-47cf-abb8-007c25478090	2024-03-17	Warnings	Exact identifier application number: M012
Childrens Robitussin Cough Long-Acting	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	75bc7827-4439-e6a8-a65c-7154d5592e58	2024-03-17	Warnings	Exact identifier application number: M012
Childrens Robitussin Nighttime Cough Long-Acting DM	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c	2024-03-17	Warnings	Exact identifier application number: M012
ANTIGRIP Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Pharmadel LLC	12f20aba-f991-bd82-e063-6294a90a4aac	2024-03-16	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	WALGREENS	d3053f80-aece-eb50-e053-2a95a90a5945	2024-03-15	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCL	WALGREENS	d315bc95-1b46-75df-e053-2a95a90a6c66	2024-03-15	Warnings	Exact identifier application number: M012
MAR-COF CG Expectorant	CODEINE PHOSPHATE AND GUAIFENESIN	Marnel Pharmaceuticals, LLC	60a41229-b125-43d8-b2b4-0bf40feed764	2024-03-15	Warnings	Exact identifier application number: M012
Night Time Cough	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY, INC	97aa0b90-1230-4143-b5d3-18b96a6b7b4f	2024-03-15	Warnings	Exact identifier application number: M012
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Haleon US Holdings LLC	036162c9-f5a6-418e-bd5e-ebd72097d27d	2024-03-15	Warnings	Exact identifier application number: M012
Bronkaid Max	EPHEDRINE SULFATE	Foundation Consumer Healthcare LLC	9a0b792a-caee-41f6-9400-922a5ebd592f	2024-03-14	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	A-S Medication Solutions	5f2b16f0-c58b-4e48-ad92-eaab93c6c4b2	2024-03-12	Warnings	Exact identifier application number: M012
Coricidin HBP Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE	A-S Medication Solutions	ffcae882-0b19-4219-bbee-a175c63d79c8	2024-03-11	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime with Honey Ginger Flavor	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	18dcede2-5a38-40fa-93fe-48acdd6a7cf1	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime with Honey Elderberry Flavor	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	d4ce06aa-776f-45e4-a1a6-9cf13797048f	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	14e38ef0-a5e7-4df7-824f-f27bef664d25	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	68d3e88a-d1be-410b-92a1-863903b3aa61	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	0d3b1bea-e2ca-4e07-8ae5-60627d230c96	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu PowerPods Daytime Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Haleon US Holdings LLC	e655c33c-c319-41d9-ae55-cf747242cd10	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime Berry Burst	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	adf33520-4689-4de2-b9d8-c201518e9d26	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	f6ae9e3a-6bea-40e0-8a6f-45f4be8319e7	2024-03-07	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
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	d3b2f300-d919-44cd-ab71-b74b5bdfd977	1
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	d3b2f300-d919-44cd-ab71-b74b5bdfd977	1
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	d3b2f300-d919-44cd-ab71-b74b5bdfd977	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
77333-231-10	77333023110	100 BLISTER PACK in 1 BOX (77333-231-10) / 1 CAPSULE in 1 BLISTER PACK (77333-231-25)	100 blister pack	2026-05-15	No	No	Current
77333-231-25	77333023125	1 in 1 BLISTER PACK					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Antihistamine - Gendose Pharmaceuticals, LLC	Gendose Pharmaceuticals, LLC	2026-05-15	HUMAN OTC DRUG LABEL	1