ALLERGY

Product NDC: 50090-0049
11-digit product format: 500900049
Labeler code: 50090
Product ID: 50090-0049_d8254c0e-4446-4c1a-8c6b-54e1d4cd9cb4
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1992-12-19
Substance: CHLORPHENIRAMINE MALEATE
Active strength: 4 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	50090-0049		E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50090-0049	50090-0049-6	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50090-0049	50090-0049-7	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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: ALLERGY
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPHENIRAMINE MALEATE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V1Q0O9OJ9Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1363309	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
b199b5ee-fff3-4746-be68-a04060586f8e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-0049-0	2023-02-07	ALLERGY
50090-0049-1	2023-02-07	ALLERGY
50090-0049-6	2023-02-07	ALLERGY
50090-0049-7	2023-02-07	ALLERGY
50090-0049-0	2023-01-30	ALLERGY
50090-0049-1	2023-01-30	ALLERGY
50090-0049-6	2023-01-30	ALLERGY
50090-0049-7	2023-01-30	ALLERGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-0049-0	ALLERGY	100 in 1 BOTTLE	TABLET	100	20
50090-0049-0	ALLERGY	1 in 1 CARTON	TABLET	1	20
50090-0049-1	ALLERGY	10 in 1 BOTTLE	TABLET	10	20
50090-0049-6	ALLERGY	20 in 1 BOTTLE	TABLET	20	20
50090-0049-7	ALLERGY	60 in 1 BOTTLE	TABLET	60	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0049-0	EA - Each	50090-0049	a08b2e8e-7a65-4834-ad42-d8cface4c544	1	2023-08-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0049	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS]	20	Current NDC, Legacy NDC, 5 package rows	20240719_b199b5ee-fff3-4746-be68-a04060586f8e.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 23 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	54254b61-7861-4eeb-bd3c-54fd5266f4a7	2026-06-08	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Major Pharmaceuticals	aa662428-e61f-4e22-af4d-8cf63df68c99	2026-06-08	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN, GUAIFENESIN AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	TARGET CORPORATION	47a218a0-6395-36bd-e063-6394a90a265a	2026-06-05	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL	TARGET CORPORATION	4779288a-9850-8490-e063-6394a90abe51	2026-06-05	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max and Mucinex Fast-Max Nighttime DM Max Value Pack	DEXTROMETHORPHAN HBR, GUAIFENESIN AND TRIPROLIDINE HCL	Reckitt Benckiser LLC	4df37cfb-299f-661f-e063-6394a90ab337	2026-06-04	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	53715ea4-42b3-5887-e063-6294a90a4249	2026-06-04	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Chain Drug Marketing Association, Inc.	b0d38db9-22a9-4dd8-8e0f-dd81805e724b	2026-06-04	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS PHARMACY	65d4d7ea-c080-404e-9836-7d6bdcc5ea7d	2026-06-04	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	fe9d6a6e-38a1-44ae-a30f-596c5ec7d057	2026-06-03	Warnings	Exact identifier application number: M012
Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	b0c1d635-0f85-433a-b479-51c68d259faa	2026-06-03	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Walgreen Company	de4e8af4-d3d0-44b3-aea3-79016803ccdc	2026-06-03	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR AND GUAIFENESIN	ARMY AND AIR FORCE EXCHANGE SERVICE	dc0a3761-bbe2-4261-a183-594f5fb12b0b	2026-06-03	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	WALMART INC.	f278cc81-65b2-4e45-be5b-41152cbb67c4	2026-06-03	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	358ba91d-06a4-49c9-994d-4e4bf9499dcd	2026-06-03	Warnings	Exact identifier application number: M012
GUAIFENESIN DM	GUAIFENESIN AND DEXTROMETHORPHAN	Cardinal Health 107, LLC	c5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed	2026-06-02	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5349dbde-730c-610f-e063-6394a90a952a	2026-06-02	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	Cardinal Health 107, LLC	a9130f36-4761-4e6b-a383-eca3db06ea93	2026-06-02	Warnings	Exact identifier application number: M012
Topcare Day Time Nite Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Topco Associates LLC	aed387e0-5a8b-4caf-a373-3e04496a4983	2026-06-02	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid Day	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	53371691-2510-5039-e063-6394a90a6ea9	2026-06-01	Warnings	Exact identifier application number: M012
Allegra Allergy 24 hour	FEXOFENADINE HYDROCHLORIDE	Select Consumer Group	2de81a41-8488-7e39-e063-6294a90a394b	2026-06-01	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1363309	chlorpheniramine maleate 4 MG Oral Tablet	PSN	b199b5ee-fff3-4746-be68-a04060586f8e	20
1363309	chlorpheniramine maleate 4 MG Oral Tablet	SCD	b199b5ee-fff3-4746-be68-a04060586f8e	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0049-0	50090004900	1 BOTTLE in 1 CARTON (50090-0049-0) / 100 TABLET in 1 BOTTLE	1 bottle	2021-04-19	0000-00-00	No	No	Current
50090-0049-1	50090004901	10 TABLET in 1 BOTTLE (50090-0049-1)	10 tablet	2021-04-23	0000-00-00	No	No	Current
50090-0049-6	50090004906	20 TABLET in 1 BOTTLE (50090-0049-6)	20 tablet	2014-11-28	0000-00-00	No	No	Current
50090-0049-7	50090004907	60 TABLET in 1 BOTTLE (50090-0049-7)	60 tablet	2014-11-28	0000-00-00	No	No	Current