Application 007638

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLOR-TRIMETON	CHLORPHENIRAMINE MALEATE	TABLET, EXTENDED RELEASE;ORAL	8MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CHLOR-TRIMETON	CHLORPHENIRAMINE MALEATE	TABLET, EXTENDED RELEASE;ORAL	12MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N007638-001	CHLOR-TRIMETON	CHLORPHENIRAMINE MALEATE	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982
N007638-002	CHLOR-TRIMETON	CHLORPHENIRAMINE MALEATE	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N007638-001	CHLOR-TRIMETON	8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N007638-002	CHLOR-TRIMETON	12MG	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N007638-001	CHLOR-TRIMETON	8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N007638-002	CHLOR-TRIMETON	12MG	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N007638-001	CHLOR-TRIMETON	8MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N007638-002	CHLOR-TRIMETON	12MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`782e0a99824c…`

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aller-chlor	CHLORPHENIRAMINE MALEATE	Rugby Laboratories	04ca3806-72be-47d4-9fea-5b0dee087683	2026-07-08	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	Cardinal Health 110, LLC. DBA Leader	aaecfda5-1a50-4d8a-9909-7153c1a22bda	2026-07-08	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy Relief	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	ee052b39-1658-4071-b081-5433c87b5e4a	2026-06-25	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
ClorRelief	CHLORPHENIRAMINE MALEATE	FERRER MEDICAL INNOVATIONS LLC	db729011-f72f-5911-e053-2a95a90a68bf	2026-05-22	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	WinCo Foods, LLC	27e911e1-6d22-4a50-8413-1809c8973cbd	2026-05-06	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy Relief	CHLORPHENIRAMINE MALEATE	Strategic Sourcing Services LLC	c9fa8d93-d9d6-4206-a13d-32b9e7555e7f	2026-04-02	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy	CHLORPHENIRAMINE MALEATE	Bi-Mart	922ec870-79d5-46be-80d8-20fb0ecd823b	2026-03-18	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy	CHLORPHENIRAMINE MALEATE	United Natural Foods, Inc. dba UNFI	0aa4ac07-bd02-46b2-9cf0-0643e0e1a2da	2026-03-10	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy Relief	CHLORPHENIRAMINE MALEATE	Topco Associates, LLC	35305aa9-4fc1-4cda-b6f0-89df64f9eeff	2026-03-10	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
allergy relief	CHLORPHENIRAMINE MALEATE	Rite Aid Corporation	b0d70488-ea1d-4c1d-bd07-53dfb0e4d03c	2026-02-18	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy Relief	CHLORPHENIRAMINE MALEATE	Amerisource Bergen	eeda80ff-212d-428e-a0c6-782f271357b4	2026-02-18	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b	2026-02-17	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy Relief	CHLORPHENIRAMINE MALEATE	CHAIN DRUG MARKETING ASSOCIATION INC	75269bcc-3bb2-49a0-8788-6b7da18796d3	2025-12-12	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
SPRINSOL	CHLORPHENIRAMINE MALEATE	FORTUNE PHARMACAL COMPANY LIMITED	01a1a91e-04ba-4526-8946-10483932b30c	2025-11-13	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
ED CHLORPED JR	CHLORPHENIRAMINE MALEATE	EDWARDS PHARMACEUTICALS, INC.	4a5e5968-1930-465a-9b8c-45ed936a0e11	2025-10-28	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Medique Chlorphen	CHLORPHENIRAMINE MALEATE	Unifirst First Aid Corporation	b3d5d161-8d4c-f1bb-e053-2a95a90a5bc5	2025-09-08	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy Relief	CHLORPHENIRAMINE MALEATE	WALMART INC.	5e6623c3-6210-4c50-94d6-5554f36876d1	2025-09-04	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy Relief	CHLORPHENIRAMINE MALEATE	Chain Drug Marketing Association, Inc.	68bda134-0a6c-431c-be2e-cbcfcfb35bd7	2025-09-04	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy Relief	CHLORPHENIRAMINE MALEATE	Walgreen Company	5e886cc6-837a-4a8d-812f-b1090bd6b1c4	2025-09-04	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE
Allergy Relief	CHLORPHENIRAMINE MALEATE	CVS PHARMACY	a645b31e-7da7-4fe6-a04f-ac794ef52494	2025-09-03	Warnings	Name fallback generic name: CHLORPHENIRAMINE MALEATE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
135	SUPPL	2015-12-29
40	SUPPL	2008-02-07
39	SUPPL	2006-01-30