G-DOLOGEN

Product NDC: 52083-683
11-digit product format: 520830683
Labeler code: 52083
Product ID: 52083-683_cb33b7c4-d41e-450e-b731-77fc4f8e1720
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dexbrompheniramine maleate
Dosage form: TABLET
Route: ORAL
Labeler: Kramer Novis
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-12-15
Substance: ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
Active strength: 500; 2 mg/1; mg/1
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: G-DOLOGEN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1
DEXBROMPHENIRAMINE MALEATE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
BPA9UT29BS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2729424	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
7a4e1d64-2510-405f-a1dc-e02a803b6fbd	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52083-683-90	G-DOLOGEN	90 in 1 BOTTLE, PLASTIC	TABLET	90		1

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 174 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIMPEX Guaifenesin	GUAIFENESIN	Simpex Pharma Pvt. Ltd	1594f9d6-0c48-42bf-b76b-d621f215179a	2023-11-29	Warnings	Exact identifier application number: M012
Stona	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	8b89f50d-88f8-4773-92ea-5ada61766056	2023-11-28	Warnings	Exact identifier application number: M012
Stona	DEXTROMETHORPHAN HYDROBROMIDE	Sato Pharmaceutical Co., Ltd.	1ccc9e56-32a4-450f-8412-5814b6aef285	2023-11-28	Warnings	Exact identifier application number: M012
Neo-Synephrine Maximum	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	ab8682a4-1f66-6709-e053-2995a90a8b4a	2023-11-16	Warnings	Exact identifier application number: M012
Neo-Synephrine Regular	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	ab860c10-b8cf-3f92-e053-2a95a90a7317	2023-11-16	Warnings	Exact identifier application number: M012
Neo-Synephrine Mild	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	9b8e9162-e4da-14d9-e053-2995a90a2269	2023-11-16	Warnings	Exact identifier application number: M012
Universal Vaporizing Chest Rub	MENTHOL AND CAMPHOR AND EUCALYPTUS	Universal Distribution Center LLC	b1d25572-da21-408d-aab3-3a0741dfff12	2023-11-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Severe, Caseys 4goog	ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATED	Lil' Drug Store Products, Inc.	0334259d-587e-b2d5-e063-6394a90a3e56	2023-11-14	Warnings	Exact identifier application number: M012
Stona Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Sato Pharmaceutical Co., Ltd.	0b638db4-5ed3-4665-abcd-f95e677adbd8	2023-11-12	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	6c90b415-4c5f-49e5-beb6-4cf225797b21	2023-11-06	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	8b8582c0-8aef-482f-9738-2f1d4e325d64	2023-11-06	Warnings	Exact identifier application number: M012
Cold and Flu Severe Daytime/Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	27ade5f8-2003-4dc6-9244-42676791e1f8	2023-11-06	Warnings	Exact identifier application number: M012
Benadryl Allergy Ultratab	DIPHENHYDRAMINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	ec2070df-8a8a-4cd1-8830-62655433fb3b	2023-11-05	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	093eed84-79b1-7914-e063-6394a90a37af	2023-11-03	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff68377-2273-6c6c-e053-2995a90a36b2	2023-11-03	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	Topco Associates LLC	096bbcaa-fce1-0fc2-e063-6294a90ad597	2023-11-03	Warnings	Exact identifier application number: M012
TopCare Nite Time SEVERE Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	adc8edf5-ebbe-4d94-9018-aa0dbe118112	2023-11-03	Warnings	Exact identifier application number: M012
MUCOSA	GUAIFENESIN	TIME CAP LABORATORIES,INC	d34ef2e8-adc2-48e5-a572-e354937daec6	2023-11-02	Warnings	Exact identifier application number: M012
Daytime Severe and Nighttime Severe cold and flu	DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	09286d15-b63f-a9de-e063-6294a90ab948	2023-11-02	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	f6cece6c-23e4-7811-e053-6394a90a106a	2023-11-02	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
BPA9UT29BS	DEXBROMPHENIRAMINE MALEATE	2391-03-9	DEXBROMPHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2729424	acetaminophen 500 MG / dexbrompheniramine maleate 2 MG Oral Tablet	PSN	7a4e1d64-2510-405f-a1dc-e02a803b6fbd	1
2729424	acetaminophen 500 MG / dexbrompheniramine maleate 2 MG Oral Tablet	SCD	7a4e1d64-2510-405f-a1dc-e02a803b6fbd	1
2729424	APAP 500 MG / dexbrompheniramine maleate 2 MG Oral Tablet	SY	7a4e1d64-2510-405f-a1dc-e02a803b6fbd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
52083-683-90	52083068390	90 TABLET in 1 BOTTLE, PLASTIC (52083-683-90)	90 tablet	2025-12-15	No	No	Current