Dexbrompherniramine Maleate and Pseudoephedrine Sulfate

Product NDC: 10702-005
11-digit product format: 107020005
Labeler code: 10702
Product ID: 10702-005_838e40fd-bd38-4b8d-abd4-45da435f1777
Type: HUMAN OTC DRUG
Nonproprietary name: Dexbrompherniramine Maleate and Pseudoephedrine Sulfate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: KVK-TECH, INC.
Application: ANDA078648
Marketing category: ANDA
Marketing start: 2018-12-17
Marketing end: 0000-00-00
Substance: DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
Active strength: 6 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10702-005		D	Discontinued by firm	2026-09-09
excluded package	package	10702-005	10702-005-03	D	Discontinued by firm	2026-09-09
excluded package	package	10702-005	10702-005-21	D	Discontinued by firm	2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	10702-005		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10702-005	10702-005-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10702-005	10702-005-03	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL			2013-02-27

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078648-001	DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE	6MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2013-02-27	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXBROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	BPA9UT29BS	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
PSEUDOEPHEDRINE SULFATE	ACTIVE INGREDIENT	Y9DL7QPE6B	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
DEXBROMPHENIRAMINE	ACTIVE MOIETY	75T64B71RP	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10702-005	DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG/120MG (DEXBROMPHERNIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [KVK-TECH, INC.]	4	Legacy NDC	20181217_cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BPA9UT29BS	DEXBROMPHENIRAMINE MALEATE	2391-03-9	DEXBROMPHENIRAMINE MALEATE
Y9DL7QPE6B	PSEUDOEPHEDRINE SULFATE	7460-12-0	PSEUDOEPHEDRINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10702-005-03	10702000503	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10702-005-03)		2018-12-17	0000-00-00	No	No	Current
10702-005-21	10702000521	2 BLISTER PACK in 1 CARTON (10702-005-21) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2 blister pack	2018-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexbrompheniramine maleate 6 mg Pseudoephedrine Sulfate 120 mg	KVK-TECH, INC. \| AVANTHI \| KVK-TECH, INC	2017-12-04	HUMAN OTC DRUG LABEL	4