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 14 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TUSSIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Safeway	a5e2bda4-2da6-4c20-855d-2888dadf0c3a	2026-07-28	Warnings	Exact identifier application number: M012
DM Maximum	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f6029b04-e681-40fc-be4f-14091b76dd4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CVS PHARMACY	e958eef1-8aae-4365-ac64-95a9e8e7e0f2	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	38400854-27fa-e291-e063-6294a90a5c4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Better Living Brands, LLC	65802aa7-64e7-4435-ad6b-65895fba17ce	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	0a48f650-ad2a-4105-9ff4-2bc4d94b46d3	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	84202ebe-97b6-4be2-bb09-7f2729303f96	2026-07-27	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	8d41defe-8120-4cbb-b42e-c805cc5a794b	2026-07-24	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	3afc88c7-388a-dbd9-e063-6294a90a4faf	2026-07-24	Warnings	Exact identifier application number: M012
Giltuss Allergy Plus	CHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	85a0dc7f-ffb5-7d52-e053-2991aa0a602a	2026-07-23	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	8590fcc9-c0dd-f43b-e053-2991aa0a692e	2026-07-23	Warnings	Exact identifier application number: M012
Giltuss Sinus and Chest Congestion	GUAIFENESIN, PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	8591003c-c2f2-df65-e053-2a91aa0a42fb	2026-07-23	Warnings	Exact identifier application number: M012
COLDTAC Plus	ACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	OPMX LLC	3496866c-682f-420b-bfdb-64ecebbf70a2	2026-07-23	Warnings	Exact identifier application number: M012
nighttime cough dm	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	5a45b4c2-6a15-40b4-9ac6-d1554244ec42	2026-07-23	Warnings	Exact identifier application number: M012
DAY TIME NITE TIME INTENSE FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	6372cbdd-a3a3-499d-91ce-53bcdb83e739	2026-07-23	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	df6e522c-3e30-4aa0-8ab9-3b579c80bcad	2026-07-22	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba	2026-07-22	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Kenvue Brands LLC	1c5386c1-e45d-9dcb-e063-6294a90aff07	2026-07-22	Warnings	Exact identifier application number: M012
Allergy plus Sinus Headache	ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG	Shield Pharmaceuticals Corp	772d0184-8c41-40f1-bbef-7e68692eec66	2026-07-22	Warnings	Exact identifier application number: M012
good sense allergy	DIPHENHYDRAMINE HCL	L. Perrigo Company	bf5039a0-2109-41a2-84a9-b5167d0a93da	2026-07-22	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