Allergy

Product NDC: 0904-0012
11-digit product format: 009040012
Labeler code: 0904
Product ID: 0904-0012_b4ea5878-6db7-4066-9ce9-02d6a334b581
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: 2027-12-31
Current FDA listing: Yes

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: 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 7 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS PHARMACY	3148f80f-8a0d-4b6c-85be-79085fc04444	2026-08-19	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	aa7164a7-f842-457d-abee-0740bb8c1c90	2026-08-19	Warnings	Exact identifier application number: M012
CVS	CHILDRENS STUFFY NOSE AND COLD	CVS PHARMACY, INC	6cff265d-94a3-4617-a366-fe970d97f05a	2026-08-19	Warnings	Exact identifier application number: M012
CVS Severe Congestion and Pain Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CVS	5a8e4320-bae1-4831-b66b-9babfe8888d6	2026-08-19	Warnings	Exact identifier application number: M012
CVS Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	CVS PHARMACY	0ae0c244-e019-4b35-890c-8e15e3d3f7ce	2026-08-19	Warnings	Exact identifier application number: M012
CVS Severe Tussin CF Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	e32881f5-2bb5-4756-aa86-a09473ab590b	2026-08-19	Warnings	Exact identifier application number: M012
Good Sense Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	L. Perrigo Company	d2541ef0-a73c-43aa-91ff-fdbce2748c4f	2026-08-18	Warnings	Exact identifier application number: M012
CVS Severe Nasal Congestion Relief Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	5a7e42ee-810c-4bc1-9d8d-fac8e849e126	2026-08-18	Warnings	Exact identifier application number: M012
DAYTIME NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	8dd039b4-209a-484a-b15e-741d55087a93	2026-08-18	Warnings	Exact identifier application number: M012
CVS Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	CVS PHARMACY	558b7ed6-a9f6-452c-90cd-df8258663bf1	2026-08-18	Warnings	Exact identifier application number: M012
Extra Strength Nasal	PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	7acf1a9a-bd97-48bb-8025-ac26070378a2	2026-08-18	Warnings	Exact identifier application number: M012
Polytussin DM	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE	Poly Pharmaceuticals, Inc.	fda8f594-82bf-1781-e053-6294a90ad344	2026-08-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max Honey and Berry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	da1f1ef9-a974-4998-8e1d-c1d999596943	2026-08-18	Warnings	Exact identifier application number: M012
CVS Health Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	89168715-71b1-424e-8dae-fcfa90bc85bf	2026-08-18	Warnings	Exact identifier application number: M012
CVS Health Sinus	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	c7840511-3a4f-4547-ae90-19b085a5874e	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health	NASAL OXYMETAZOLINE HCL	CVS Pharmacy,Inc.	56f08e70-bf16-4933-97bc-177bc190d12a	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health No Drip	ALLERGY NASAL	CVS PHARMACY,INC.	3e76ffac-07a7-4b6a-bc4c-9cabb653e064	2026-08-17	Warnings	Exact identifier application number: M012
CVS dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY	db5a5eff-1bb1-4d00-8c01-caae7a1c7223	2026-08-17	Warnings	Exact identifier application number: M012
CVS Overnight Cold and Flu Clear and Cool	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	CVS PHARMACY, INC	2497a011-d7a0-4d69-97e2-bbf25a99b1cc	2026-08-17	Warnings	Exact identifier application number: M012
Mucus Relief Cough Cold Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	H E B	3ef949f5-ac8c-44be-b04d-6996fa59a94b	2026-08-17	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