ALA-HIST IR

Product NDC: 50991-783
11-digit product format: 509910783
Labeler code: 50991
Product ID: 50991-783_4513db4f-e8f2-ecc6-e063-6294a90a1b17
Type: HUMAN OTC DRUG
Nonproprietary name: Dexbrompheniramine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Poly Pharmaceuticals, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-08-22
Substance: DEXBROMPHENIRAMINE MALEATE
Active strength: 2 mg/1
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: ALA-HIST IR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXBROMPHENIRAMINE MALEATE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BPA9UT29BS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2262293	Internal RxNorm lookup
2262295	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
0d203b5c-8b10-428b-8703-17be6b4ce6eb	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50991-783-02	ALA-HIST IR	1 in 1 BLISTER PACK	TABLET	1	11
50991-783-02	ALA-HIST IR	12 in 1 CARTON	TABLET	12	11
50991-783-60	ALA-HIST IR	60 in 1 BOTTLE, PLASTIC	TABLET	60	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50991-783-60	EA - Each	50991-783	9c42708d-fac3-4149-b21e-c6e82426a3d4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXBROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	BPA9UT29BS	ALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]	4
DEXBROMPHENIRAMINE	ACTIVE MOIETY	75T64B71RP	ALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]	4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	ALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50991-783	ALA-HIST IR (DEXBROMPHENIRAMINE MALEATE) TABLET [POLY PHARMACEUTICALS, INC.]	10	Current NDC, Legacy NDC, 3 package rows	20240711_0d203b5c-8b10-428b-8703-17be6b4ce6eb.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 5 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUCUS RELIEF	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	5afb242f-fac9-dc81-e063-6394a90a8448	2026-08-27	Warnings	Exact identifier application number: M012
daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Amazon.com Services LLC	6de619d3-0ab0-43e7-8dac-7bbd5368ac65	2026-08-27	Warnings	Exact identifier application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI	Walgreens	366ddac8-9e8a-41bd-a7f7-48213485a5f8	2026-08-27	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Walgreens	37896933-3ed3-457f-8a32-ee0d784a19e8	2026-08-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Amazon.com Services LLC	298e9164-e378-4b39-a944-bfc8f8baa4de	2026-08-27	Warnings	Exact identifier application number: M012
DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum Strength	DAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Walgreens	3b4b3b04-eff9-4e06-8b37-f6729671d07f	2026-08-27	Warnings	Exact identifier application number: M012
Daytime Cold and Flu mini Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	dfb0fe2e-b0c7-409a-bd1a-fd12485665ba	2026-08-26	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	70c5517d-be4e-4317-b4f4-df660c71c699	2026-08-26	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d	2026-08-26	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	5b95905e-b729-4caf-921a-fc4ef815289c	2026-08-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	c88e93d4-66b6-4327-b9e5-0e0a95a18d66	2026-08-25	Warnings	Exact identifier application number: M012
Sleep Aid NightTime	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4fff664b-4ff0-4007-95ab-cb273807b9b4	2026-08-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	7d972559-6184-476b-9cbf-1bc5663ea00d	2026-08-24	Warnings	Exact identifier application number: M012
Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	9be8437c-6053-4ed4-bdd2-97f556b5289e	2026-08-24	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE	Kenvue Brands LLC	594f515c-b369-816d-e063-6294a90a59a1	2026-08-21	Warnings	Exact identifier application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLD	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, LLC	47ddbb0d-0823-4817-9c56-e7fff77d601c	2026-08-21	Warnings	Exact identifier application number: M012
Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	DOLGENCORP, LLC	5be4e730-3cd6-414e-a23b-f6cad8088750	2026-08-21	Warnings	Exact identifier application number: M012
Mucus Relief DM Cough Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Cardinal Health 110, LLC. DBA Leader	6304a581-9238-4539-b157-293fc05c173e	2026-08-21	Warnings	Exact identifier application number: M012
COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ct	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	HyVee Inc	82ead335-d38e-40c3-8031-222bf985a302	2026-08-20	Warnings	Exact identifier application number: M012
HyVee Nighttime Severe Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	49818610-bf4a-fb86-e063-6294a90ae598	2026-08-20	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BPA9UT29BS	DEXBROMPHENIRAMINE MALEATE	2391-03-9	DEXBROMPHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2262295	ALA-HIST IR 2 MG Oral Tablet	PSN	0d203b5c-8b10-428b-8703-17be6b4ce6eb	11
2262293	dexbrompheniramine maleate 2 MG Oral Tablet	PSN	0d203b5c-8b10-428b-8703-17be6b4ce6eb	11
2262295	dexbrompheniramine maleate 2 MG Oral Tablet [Ala-Hist IR]	SBD	0d203b5c-8b10-428b-8703-17be6b4ce6eb	11
2262293	dexbrompheniramine maleate 2 MG Oral Tablet	SCD	0d203b5c-8b10-428b-8703-17be6b4ce6eb	11
2262295	Ala-Hist IR (dexbrompheniramine maleate 2 MG) Oral Tablet	SY	0d203b5c-8b10-428b-8703-17be6b4ce6eb	11
2262295	Ala-Hist IR 2 MG Oral Tablet	SY	0d203b5c-8b10-428b-8703-17be6b4ce6eb	11
2262295	AlaHist IR 2 MG Oral Tablet	SY	0d203b5c-8b10-428b-8703-17be6b4ce6eb	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50991-783-02	50991078302	12 BLISTER PACK in 1 CARTON (50991-783-02) / 1 TABLET in 1 BLISTER PACK	12 blister pack	2011-08-22	0000-00-00	No	No	Current
50991-783-60	50991078360	60 TABLET in 1 BOTTLE, PLASTIC (50991-783-60)	60 tablet	2011-08-22	0000-00-00	No	No	Current