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 |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
| DEXBROMPHENIRAMINE MALEATE | 2 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| BPA9UT29BS | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2729424 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7a4e1d64-2510-405f-a1dc-e02a803b6fbd | Available on FDA.report |
DailyMed Package Descriptions#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nighttime Ultra Concentrated Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELS | WALGREENS | 2be0a699-e6ad-ef56-e063-6394a90aaca5 | 2025-04-03 | Warnings | M012 |
| Cough and Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 44fb27d3-5125-4511-84d2-76555bc46e66 | 2025-04-03 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | KESIN PHARMA CORPORATION | 31b8ad0a-3637-03db-e063-6394a90acdc3 | 2025-04-01 | Warnings | M012 |
| Pharmacys Prescription Vapor Rub | MENTHOL | American Consumer Products Corp | 31aa54d8-df8d-f1ae-e063-6294a90a9622 | 2025-03-31 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Bryant Ranch Prepack | 570a71eb-2d19-4c7b-8c00-e1524bfa3844 | 2025-03-31 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | KESIN PHARMA CORPORATION | 365c01b7-a197-4876-85fc-42204f787e3a | 2025-03-28 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | Bryant Ranch Prepack | 59aeb692-2f79-45aa-8e6a-dab77cd3b2f9 | 2025-03-28 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Oncor Pharmaceuticals | 06ecba97-c790-4672-a8c3-f9caf6272d26 | 2025-03-27 | Warnings | M012 |
| Sugar Free Honey-Lemon Fishermans Friend Menthol Cough Suppressant | MENTHOL | Lofthouse of Fleetwood, Ltd. | 87ebb4d9-78d7-1c87-e053-2a95a90adb7d | 2025-03-27 | Warnings | M012 |
| REVASOL CHILDRENS ALLERGY | DIPHENHYDRAMINE HCL | Rnv LLC | 3143137f-ef42-5358-e063-6394a90a8ed1 | 2025-03-26 | Warnings | M012 |
| Rompe Pecho SF FLU | DEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Efficient Laboratories Inc | bc10695a-9664-4ce3-82bb-820da06129fa | 2025-03-26 | Warnings | M012 |
| SUPRESS-PE Pediatric | GUIAFENESIN, PHENYLEPHRINE HCL | Kramer Novis | a474171d-5c29-4a80-9d37-00613796211a | 2025-03-26 | Warnings | M012 |
| Guaifenesin DM | DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN | Innovida Pharmaeutique Corporation | dd3f806b-2470-4055-94e1-18adac811025 | 2025-03-25 | Warnings | M012 |
| Foster and Thrive childrens cold cough relief dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Strategic Sourcing Services LLC | 38b710e3-1d01-4ff4-a6b6-44936f277f49 | 2025-03-25 | Warnings | M012 |
| Revasol Tussin DM Max with Honey | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Rnv LLC | 30da9255-c93a-84d6-e063-6394a90a7c2a | 2025-03-21 | Warnings | M012 |
| REVASOL NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Rnv LLC | 30dfd8f7-4cc6-d4f2-e063-6394a90aa9c9 | 2025-03-21 | Warnings | M012 |
| Chest Congestion Relief | GUAIFENESIN | Meijer, Inc. | 261a79b3-5704-76f2-e063-6394a90a5ac6 | 2025-03-20 | Warnings | M012 |
| Rompe Tos X Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05cc932d-b412-0710-e063-6394a90a87f6 | 2025-03-19 | Warnings | M012 |
| Rompe Tos X Adults | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05abb2db-d22e-90b5-e063-6294a90ace3f | 2025-03-19 | Warnings | M012 |
| Sinus Head Congestion | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 30a07773-bd6f-b9f2-e063-6394a90ab8aa | 2025-03-18 | Warnings | M012 |
DailyMed RxNorm Mappings#
| 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 | 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 |