FDA.reportPublic FDA data

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
IngredientStrength
ACETAMINOPHEN500 mg/1
DEXBROMPHENIRAMINE MALEATE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
BPA9UT29BSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2729424Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7a4e1d64-2510-405f-a1dc-e02a803b6fbdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-683-90G-DOLOGEN90 in 1 BOTTLE, PLASTICTABLET901

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 117 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcf2dd1fb-1d5b-428e-8c9a-a46dbd7cb6452025-05-07WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC2b962d87-6ff5-4c0f-8504-e5b61c9406122025-05-05WarningsExact identifier
application number: M012
Cough and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUIDCVS2d13564a-e8d1-c357-e063-6394a90ad90e2025-05-02WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling MentholOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33fe0e49-3de5-8afd-e063-6294a90a0ad52025-05-02WarningsExact identifier
application number: M012
Daytime and Nighttime High Blood Pressure Cold and Flu LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy, Inc.2d13964a-8cc4-f3dc-e063-6394a90aa1052025-05-02WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HCL 12.5 MG PER 5 MLDIPHENHYDRAMINE HCL 12.5 MG PER 5 MLAARNA USA INC.32c26835-f54e-d7e5-e063-6294a90ae1c02025-04-30WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33e6239b-364a-0e62-e063-6294a90a50472025-04-29WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCVS Pharmacy8296049c-72fc-4200-9d45-c8e377314cf22025-04-29WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEAurohealth LLC70e1bd25-c32e-491f-b383-91d6f74957a02025-04-28WarningsExact identifier
application number: M012
Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HCLCVS Pharmacy70914691-220c-4fce-9ee1-61a51e8864bc2025-04-26WarningsExact identifier
application number: M012
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions810ce630-41be-4e15-b64a-d70f63abaf622025-04-24WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B5f945975-224f-43eb-b129-a61e3b25c4bb2025-04-22WarningsExact identifier
application number: M012
Walgreens Severe Honey Lemon Throat DropsMENTHOLWalgreens334a9348-2a44-5c94-e063-6394a90ae9562025-04-21WarningsExact identifier
application number: M012
meijer Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bd85bc3-e600-583d-e063-6294a90a7be12025-04-18WarningsExact identifier
application number: M012
Daytime Nighttime Ultra ConcentratedDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKROGER COMPANY2be4a37b-44e1-8a8e-e063-6394a90a26a92025-04-17WarningsExact identifier
application number: M012
good neighbor pharmacy childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEAmerisource Bergencde0fd43-771f-4528-bad2-5727efec52502025-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC729ab412-f30b-4ad1-9d8f-1a5e1c48b1182025-04-16WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.9382c976-3067-4923-a38f-101d1c481e972025-04-11WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HCL LIQUID FILLED CAPSULESWalmart Inc.263d31c8-bdc2-a289-e063-6394a90a4aaa2025-04-10WarningsExact identifier
application number: M012
CVS Wild Cherry Throat DropPECTINCVS31f4b641-e9c0-786e-e063-6394a90aa2532025-04-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2729424acetaminophen 500 MG / dexbrompheniramine maleate 2 MG Oral TabletPSN7a4e1d64-2510-405f-a1dc-e02a803b6fbd1
2729424acetaminophen 500 MG / dexbrompheniramine maleate 2 MG Oral TabletSCD7a4e1d64-2510-405f-a1dc-e02a803b6fbd1
2729424APAP 500 MG / dexbrompheniramine maleate 2 MG Oral TabletSY7a4e1d64-2510-405f-a1dc-e02a803b6fbd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52083-683-905208306839090 TABLET in 1 BOTTLE, PLASTIC (52083-683-90) 90 tablet2025-12-15NoNoCurrent