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 10 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRIPROLIDINE HYDROCHLORIDE	TRIPROLIDINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	4eeffb6d-fc5e-48bc-95f6-ec4d5cb6e0d2	2026-08-10	Warnings	Exact identifier application number: M012
TRIPROLIDINE HYDROCHLORIDE	TRIPROLIDINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	a9f01760-e335-4410-a9b8-8edce2841270	2026-08-10	Warnings	Exact identifier application number: M012
Guaifed	GUAIFENESIN	Aldama Pharmaceuticals, Inc	38f37272-2084-a33b-e063-6294a90ac150	2026-08-10	Warnings	Exact identifier application number: M012
Chlorpheniramine Maleate	CHLORPHENIRAMINE MALEATE	PD-Rx Pharmaceuticals, Inc.	7a3452a2-930f-48b1-8c59-dbceb10b9c78	2026-08-10	Warnings	Exact identifier application number: M012
Guaifed DM	DEXTROMETHORPHAN, GUAIFENESIN	Aldama Pharmaceuticals, Inc	396bf716-0f61-9563-e063-6394a90a171b	2026-08-10	Warnings	Exact identifier application number: M012
Daytime Cold and Flu mini Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	eff114fe-fb15-48dd-b673-4d4d66406e69	2026-08-10	Warnings	Exact identifier application number: M012
Sleep Aid	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	651b03a3-b85e-4028-a9f2-472bec16c8f4	2026-08-10	Warnings	Exact identifier application number: M012
NASAL	PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	02a89765-2a75-470a-9fd6-8cce71dc19e9	2026-08-10	Warnings	Exact identifier application number: M012
WINCO Maximum StrengthCold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WINCO FOODS, LLC	f34bfb71-2c81-44d0-a2a0-4d320c43c217	2026-08-07	Warnings	Exact identifier application number: M012
DAYTIME NIGHTTIME ELDERBERRY COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreen Company	11cac20e-9bb6-4e2d-8efd-4451f055c7b4	2026-08-07	Warnings	Exact identifier application number: M012
Winco Foods Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WINCO FOODS, LLC	1d02b32a-e88d-4c70-b66d-7bdc22c25a43	2026-08-07	Warnings	Exact identifier application number: M012
foster and thrive daytime cold and flu relief nighttime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	c1ecc56b-8052-4b0a-900a-dc93a24771bd	2026-08-07	Warnings	Exact identifier application number: M012
Adult Long Lasting Cough Relief	DEXTROMETHORPHAN HBR	Shield Pharmaceuticals Corp	bbf7d296-fa3d-43e5-984c-e9d2881a074d	2026-08-07	Warnings	Exact identifier application number: M012
Severe Cold and Cough Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	WinCo Foods, LLC	790d534a-0f40-495b-a815-67851ac3d20d	2026-08-07	Warnings	Exact identifier application number: M012
Extra Moisturizing Nasal Pump Mist Anti Drip	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	46ebd262-c6a4-43ea-a7f6-506561bb3de4	2026-08-07	Warnings	Exact identifier application number: M012
Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	WINCO FOODS, LLC	e6afa830-6ce2-4abc-b5c9-3f5f156444df	2026-08-07	Warnings	Exact identifier application number: M012
Sinus PE Pressure plus Pain MAXIMUM STRENGTH	ACETAMINOPHEN, PHENYLEPHRINE HCL	CVS Pharmacy	a3b073b4-494c-4531-b08e-475c86ba321d	2026-08-07	Warnings	Exact identifier application number: M012
Severe Cold and Cough Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	WinCo Foods, LLC	dc56197c-c108-4b35-b791-dde5c3384ddd	2026-08-07	Warnings	Exact identifier application number: M012
Sinus Severe Non Drowsy, Daytime	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	84c30ec9-a7b5-4d2f-95b2-d6fb895945de	2026-08-07	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	887cabe5-46d0-4f4e-8f5a-2cfdbc157b58	2026-08-07	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