Chlorphen-12

Product NDC: 10702-017
Requested package NDC: 10702-017-54
11-digit product format: 107020017
Labeler code: 10702
Product ID: 10702-017_7d67f785-a25f-1819-e053-2991aa0a11d3
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorpheniramine Maleate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: KVK-Tech, Inc.
Application: ANDA040829
Marketing category: ANDA
Marketing start: 2010-06-15
Substance: CHLORPHENIRAMINE MALEATE
Active strength: 12 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040829-001	CHLORPHENIRAMINE MALEATE	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL		RS	2009-05-13

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040829-001	CHLORPHENIRAMINE MALEATE	12MG	TABLET, EXTENDED RELEASE / ORAL	RS	2009-05-13	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Chlorphen-12
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPHENIRAMINE MALEATE	12 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
1363288	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
84409269-fe9b-469e-9a66-27b1475231a3	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
10702-017-01	Chlorphen-12	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	4
10702-017-04	Chlorphen-12	4 in 1 PACKAGE	TABLET, FILM COATED, EXTENDED RE	4	4
10702-017-06	Chlorphen-12	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	4
10702-017-24	Chlorphen-12	24 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	24	4
10702-017-54	Chlorphen-12	50 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	50	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10702-017-06	EA - Each	10702-017	f305b502-0c47-4323-8289-8c165c899940	1	2013-02-13
10702-017-24	EA - Each	10702-017	88273ebc-e706-4a95-8da1-91eb4ffe9cd6	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	CHLORPHENIRAMINE MALEATE TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10702-017	CHLORPHEN-12 (CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]	4	Current NDC, Legacy NDC, 5 package rows	20181220_84409269-fe9b-469e-9a66-27b1475231a3.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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorphen-12	CHLORPHENIRAMINE MALEATE	KVK-Tech, Inc.	84409269-fe9b-469e-9a66-27b1475231a3	2018-12-19	Warnings	Exact identifier application applno (ANDA): 040829 application number: ANDA040829 ndc (package): 10702-017-54 ndc (product): 10702-017 ndc11 (package): 10702001754
Allergy Relief	CHLORPHENIRAMINE MALEATE	CVS Pharmacy	626aa162-f5e3-45c0-b5ac-d70bff255aed	2017-01-19	Warnings	Exact identifier application applno (ANDA): 040829 application number: ANDA040829

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
1363288	chlorpheniramine maleate 12 MG 12HR Extended Release Oral Tablet	PSN	84409269-fe9b-469e-9a66-27b1475231a3	4
1363288	12 HR chlorpheniramine maleate 12 MG Extended Release Oral Tablet	SCD	84409269-fe9b-469e-9a66-27b1475231a3	4
1363288	chlorpheniramine maleate 12 MG 12 HR Extended Release Oral Tablet	SY	84409269-fe9b-469e-9a66-27b1475231a3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10702-017-54	10702001754	50 PACKAGE in 1 CARTON (10702-017-54) / 4 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (10702-017-04)	50 package	2018-11-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorphen-12 - Cold FAid	Cold FAid	2021-01-19	HUMAN OTC DRUG LABEL	2
Chlorphen-12 (Chlorpheniramine Maleate) Extended-Release Tablets, 12 mg	KVK-Tech, Inc. \| Avanthi, Inc.	2018-12-19	HUMAN OTC DRUG LABEL	4