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 17 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flu HBP Maximum Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Rite Aid Corporation	f1a4ee57-33a3-4791-a769-b208b38acb72	2026-07-13	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY Childrens Allergy Relief	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	c499574c-f32b-4608-bf8b-51ad44e35725	2026-07-13	Warnings	Exact identifier application number: M012
Good NeighborChildrens Allergy Relief Bubblegum flavor	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	f442c61b-7d2c-401c-b862-acbe2282927b	2026-07-13	Warnings	Exact identifier application number: M012
Sanatos	MENTHOL	Pharmadel LLC	5683b099-f029-2d08-e063-6394a90ad482	2026-07-13	Warnings	Exact identifier application number: M012
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f673cdeb-4f8b-46b4-be92-c725d74abc55	2026-07-13	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	e4fca5ba-2d45-4c38-b0fd-297159d1705a	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	AMERISOURCE BERGEN	0269c0fd-0d8f-4264-9025-d4dcb3c45c60	2026-07-13	Warnings	Exact identifier application number: M012
Propolis Cooling Relief Cherry Cough Drops	MENTHOL, UNSPECIFIED FORM	Beekeeper's Naturals USA Inc	7087566d-f24a-4508-aa25-7f42d055c43e	2026-07-13	Warnings	Exact identifier application number: M012
Sinus Pressure and Congestion Relief	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Rite Aid Corporation	35bcf263-3296-4d9c-84c0-146a173d6e87	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Childrens Cough Relief Cherry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	AMERISOURCE BERGEN	a8e2fd43-b801-41ae-8d79-8ecf4a771543	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor No Drip Nasal Mist Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	AMERISOURCE BERGEN	7872aadd-b23c-431f-8048-24eece25ca2d	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	AMERISOURCE BERGEN	404a3521-8340-4476-a068-0e69cd0e514f	2026-07-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab5	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Long Acting Cough Adult Tussin	DEXTROMETHORPHAN HBR	AMERISOURCE BERGEN	df3c76bd-bd5b-42d7-a5f1-560fd3cba646	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Adult Tussin Mucus and chest congestion	GUAIFENESIN	AMERISOURCE BERGEN	97e9cd18-dd55-4a26-80e3-4c17b9e1a1e8	2026-07-13	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	AMERISOURCE BERGEN	a217ca8a-1c00-4816-bc26-cc0f71c80c90	2026-07-13	Warnings	Exact identifier application number: M012
Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	1ddc04fb-069c-44fe-814b-ba4f503c4be0	2026-07-10	Warnings	Exact identifier application number: M012
COUGH DROPS- menthol granule	MENTHOL GRANULE	Anhui Jiuhe Health Industry Co., Ltd	5351b943-5830-e4e7-e063-6394a90a5b66	2026-07-10	Warnings	Exact identifier application number: M012
ValuMeds Nasal Decongestant PE Phenylephrine	PHENYLEPHRINE HYDROCHLORIDE	Cabinet Health P.B.C.	3f284420-87c1-4c17-99e5-bc569bf9d45f	2026-07-10	Warnings	Exact identifier application number: M012
Severe Congestion and Cough Multi-Symptom Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS Pharmacy	707eb066-cdfc-444b-833a-9d6d133d48e4	2026-07-10	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