Allergy

Product NDC: 0904-0012
11-digit product format: 009040012
Labeler code: 0904
Product ID: 0904-0012_bcc8737e-6bf0-4d42-991f-0bdce5bbd875
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
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

Additional Listing Data#

Finished product: Yes
Brand name base: Allergy
Listing expiration: 2027-12-31

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
66b918d3-5c37-4889-b981-819ced8b6147	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-0012-24	Allergy	2 in 1 CARTON	TABLET	2	25
0904-0012-24	Allergy	12 in 1 BLISTER PACK	TABLET	12	25
0904-0012-59	Allergy	1 in 1 CARTON	TABLET	1	25
0904-0012-59	Allergy	100 in 1 BOTTLE, PLASTIC	TABLET	100	25
0904-0012-61	Allergy	10 in 1 BLISTER PACK	TABLET	10	25
0904-0012-61	Allergy	10 in 1 CARTON	TABLET	10	25
0904-0012-80	Allergy	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-0012-24	EA - Each	0904-0012	18a08f0f-7a10-4ded-b696-89ff949ef91a	1	2013-08-02
0904-0012-59	EA - Each	0904-0012	41cf3f5e-54c3-4819-9f98-441882d0f47c	1	2013-08-02
0904-0012-61	EA - Each	0904-0012	15e3010e-94b9-46dd-883d-957f017c4025	1	2013-02-13
0904-0012-80	EA - Each	0904-0012	09b8fe40-cac3-4727-b7ff-7579715ad9f3	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]	8
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]	8
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]	8
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE TABLET [DIRECT RX]	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	CHLORPHENIRAMINE MALEATE TABLET [DIRECT RX]	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	CHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	CHLORPHENIRAMINE MALEATE TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORPHENIRAMINE MALEATE TABLET [DIRECT RX]	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 [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CHLORPHENIRAMINE MALEATE TABLET [DIRECT RX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHLORPHENIRAMINE MALEATE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CHLORPHENIRAMINE MALEATE TABLET [CONTRACT PHARMACY SERVICES-PA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-0012	ALLERGY (CHLORPHENIRAMINE MALEATE) TABLET [MAJOR PHARMACEUTICALS]	24	Current NDC, Legacy NDC, 7 package rows	20250306_66b918d3-5c37-4889-b981-819ced8b6147.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 1 of 195 · 3,895 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Geiss, Destin & Dunn Inc.	1ea07a01-8779-48c2-a287-b7be866cce7b	2026-09-10	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy Relief	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	d64fe757-9948-4727-b5dd-1f8e4e4763e2	2026-09-10	Warnings	Exact identifier application number: M012
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	Kroger Company	fd41e4a4-330f-4409-8ba3-0b3bb6f45bca	2026-09-10	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid Berry Flavor	DIPHENHYDRAMINE HYDROCHLORIDE	Raritan Pharmaceuticals Inc	303d7651-9c8f-4a14-9f2c-7181fa0f003e	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Fruit Punch	GUAIFENESIN	Raritan Pharmaceuticals Inc	a19d7e1c-c04e-41c6-8af6-ecde96299216	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	2cb3e17f-3858-4773-a53f-0860ae6ff1b9	2026-09-09	Warnings	Exact identifier application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	3856c1e4-814f-85c4-e063-6394a90ab8a8	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Long Acting Cough	DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	875b40bd-7955-4048-abbf-7f43d9ea3ac5	2026-09-09	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Rite Aid Corporation	4b8ae971-ab57-4937-a878-72d905d7b849	2026-09-09	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	82ba9a73-60ef-49fd-960f-5ca2bb79555e	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN	The Kroger Co.	49829083-5c0a-4620-bfb3-7103642368db	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Childrens Stuffy Nose and Chest Congestion	GUAIFENESIN AND PHENYLEPHRINE HCL	RARITAN PHARMACEUTICALS	7a3bb739-ff50-4d29-b270-d6b084906493	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice Children daytime Cough and Chest Congestion	DEXTROMETHORPHAN HBR AND GUAIFENESIN	RARITAN PHARMACEUTICALS	25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9	2026-09-09	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Raritan Pharmaceuticals Inc	8a166067-b492-4742-b74c-28fac87c8d70	2026-09-09	Warnings	Exact identifier application number: M012
DRx Choice maximum strength Severe Cough plus sore throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	RARITAN PHARMACEUTICALS	a096cb76-0d1c-4ca8-854a-5199da0bc8f7	2026-09-09	Warnings	Exact identifier application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	efb69cc1-a745-6efc-e053-2a95a90abdc9	2026-09-08	Warnings	Exact identifier application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	The Procter & Gamble Manufacturing Company	efb5f0b9-9825-ab23-e053-2995a90a26ab	2026-09-08	Warnings	Exact identifier application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTION	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	The Procter & Gamble Manufacturing Company	f4328b44-cdfa-41aa-e053-2995a90a2728	2026-09-08	Warnings	Exact identifier application number: M012
Vicks childrens Cough Congestion	PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN	The Procter & Gamble Manufacturing Company	e2356457-9791-3710-e053-2995a90ad140	2026-09-08	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	077fac1a-0ec5-40d9-8861-a281b48f650a	2026-09-08	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	c948e612-a491-4ad0-adb9-cf31ef76e4d8	104
1363309	chlorpheniramine maleate 4 MG Oral Tablet	SCD	c948e612-a491-4ad0-adb9-cf31ef76e4d8	104
1363309	chlorpheniramine maleate 4 MG Oral Tablet	PSN	66b918d3-5c37-4889-b981-819ced8b6147	25
1363309	chlorpheniramine maleate 4 MG Oral Tablet	SCD	66b918d3-5c37-4889-b981-819ced8b6147	25
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
1363309	chlorpheniramine maleate 4 MG Oral Tablet	PSN	2dbd56d5-2bb5-4697-b7cb-e4c154321997	3
1363309	chlorpheniramine maleate 4 MG Oral Tablet	PSN	4c59bf7c-eb93-4792-9326-0076e7c55c39	3
1363309	chlorpheniramine maleate 4 MG Oral Tablet	SCD	2dbd56d5-2bb5-4697-b7cb-e4c154321997	3
1363309	chlorpheniramine maleate 4 MG Oral Tablet	SCD	4c59bf7c-eb93-4792-9326-0076e7c55c39	3
1363309	chlorpheniramine maleate 4 MG Oral Tablet	PSN	4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f	1
1363309	chlorpheniramine maleate 4 MG Oral Tablet	PSN	59e179f8-acdb-4306-bd4f-24350d9171b1	1
1363309	chlorpheniramine maleate 4 MG Oral Tablet	SCD	4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f	1
1363309	chlorpheniramine maleate 4 MG Oral Tablet	SCD	59e179f8-acdb-4306-bd4f-24350d9171b1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-0012-24	00904001224	2 BLISTER PACK in 1 CARTON (0904-0012-24) / 12 TABLET in 1 BLISTER PACK	2 blister pack	1992-12-19	0000-00-00	No	No	Current
0904-0012-59	00904001259	1 BOTTLE, PLASTIC in 1 CARTON (0904-0012-59) / 100 TABLET in 1 BOTTLE, PLASTIC		1992-12-19	0000-00-00	No	No	Current
0904-0012-61	00904001261	10 BLISTER PACK in 1 CARTON (0904-0012-61) / 10 TABLET in 1 BLISTER PACK	10 blister pack	1992-12-19	0000-00-00	No	No	Current
0904-0012-80	00904001280	1000 TABLET in 1 BOTTLE, PLASTIC (0904-0012-80)	1000 tablet	1992-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major 44-194	Major Pharmaceuticals \| LNK International, Inc.	2026-08-03	HUMAN OTC DRUG LABEL	26
Major 44-194	Bryant Ranch Prepack	2025-05-12	HUMAN OTC DRUG LABEL	104
ALLERGY	A-S Medication Solutions	2024-07-18	HUMAN OTC DRUG LABEL	20
Major 44-194	REMEDYREPACK INC.	2022-02-10	HUMAN OTC DRUG LABEL	3
Major 44-194	Preferred Pharmaceuticals Inc.	2020-04-17	HUMAN OTC DRUG LABEL	3
CHLORPHENIRAMINE MALEATE	DIRECT RX	2015-12-08	HUMAN OTC DRUG LABEL	3
Major 44-194	Aidarex Pharmaceuticals LLC	2013-12-16	HUMAN OTC DRUG LABEL	1
Chlorpheniramine Maleate	Contract Pharmacy Services-PA	2011-01-10	HUMAN OTC DRUG LABEL	1