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 33 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Halls Variety Pack Mentholyptus Honey Lemon Cherry	MENTHOL	Mondelez Global LLC	512a9a2e-6160-80d1-e063-6394a90aeff0	2026-05-08	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5150ff85-85bb-9cd9-e063-6294a90a1144	2026-05-08	Warnings	Exact identifier application number: M012
Dr. Simi Children s Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Farmacias De Similares TX LLC	5151740a-8270-7bb5-e063-6294a90ae387	2026-05-08	Warnings	Exact identifier application number: M012
Kids Allergy	DIPHENHYDRAMINE HCL	Genexa Inc.	a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec4	2026-05-08	Warnings	Exact identifier application number: M012
day time non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Publix Super Markets Inc	f4fd597f-bca2-4ed4-b353-6c734f2f885c	2026-05-08	Warnings	Exact identifier application number: M012
Daytime Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS Pharmacy	d8339bb0-5da3-4f34-a819-339643cf4a97	2026-05-08	Warnings	Exact identifier application number: M012
severe tussin cf	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	a26afc33-533e-4dc0-ab25-21be87356e22	2026-05-08	Warnings	Exact identifier application number: M012
SEVERE CONGESTION and COUGH MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	cdd53eba-1fa2-49c1-b03d-c32f309da7fb	2026-05-08	Warnings	Exact identifier application number: M012
Benadryl Allergy Liqui-Gels	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	bfeae100-e2d1-4607-be3b-2d9b15cd4f7f	2026-05-07	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	H E B	6503761f-37ae-4f39-b727-cb75d4c4a3c9	2026-05-07	Warnings, Adverse reactions	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOPCO ASSOCIATES LLC	ad199488-a4be-4b6e-b806-67ce8a6e907e	2026-05-07	Warnings	Exact identifier application number: M012
good sense nasal	OXYMETAZOLINE HCL	L. Perrigo Company	5d42adb9-3625-4072-a6b1-29a229f255c8	2026-05-07	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	4856cd7b-ccdf-4546-9c65-236ebaac3dca	2026-05-06	Warnings	Exact identifier application number: M012
Mucus Relief All in One Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	0f8928a1-97ef-4128-b8d2-20bdb6e5b6ac	2026-05-06	Warnings	Exact identifier application number: M012
daytime cough and chest congestion dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	175cc2d0-0202-4e38-8af2-9fc126b7412d	2026-05-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	HHH Pharmaceuticals	90fae0fa-da07-4ea8-bdbd-39c2ed99ae59	2026-05-06	Warnings	Exact identifier application number: M012
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	HHH Pharmaceuticals	5d8b980f-0011-41e3-a881-ad10fe399079	2026-05-06	Warnings	Exact identifier application number: M012
HALLS Mentholyptus	MENTHOL	Mondelez Global LLC	38d12374-e2c7-444c-e063-6294a90a42b3	2026-05-06	Warnings	Exact identifier application number: M012
HALLS Mentholyptus	MENTHOL	Mondelez Global LLC	1ab295ff-94b1-c938-e063-6294a90a98fd	2026-05-06	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	512af63d-2f09-4baa-e063-6394a90a86bd	2026-05-06	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