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 |
|---|---|---|---|---|---|---|
| Pediacare Childrens Cough and Congestion Grape | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH | 9576723b-748c-45e7-bc0d-cc109b9f6735 | 2024-12-30 | Warnings | M012 |
| Cold and Flu Nighttime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Lil' Drug Store Products, Inc. | ef6836fa-d104-d7b3-e053-2a95a90af2b8 | 2024-12-30 | Warnings | M012 |
| Circle K Congestion Relief | OXYMETAZOLINE HYDROCHLORIDE | Lil' Drug Store Products, Inc | 7e02fe57-f42f-4d3c-9002-4c4c0b1fafd6 | 2024-12-30 | Warnings | M012 |
| SDA Laboratories Tussin | GUAIFENESIN | SDA Laboratories, Inc. | 2a444cc8-96be-9432-e063-6394a90a1b63 | 2024-12-27 | Warnings | M012 |
| SDA Laboratories Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | SDA Laboratories, Inc. | 2a445f31-818d-11b1-e063-6294a90a8cb1 | 2024-12-27 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Richmond Pharmaceuticals Inc. | f184b2aa-91a4-44f9-b688-d4e318181984 | 2024-12-26 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Richmond Pharmaceuticals, Inc. | 2792032a-ff0f-4d5f-a8e3-b8b8c54f4e99 | 2024-12-26 | Warnings | M012 |
| OXYMETAZOLINE HYDROCHLORIDE | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC. | c7b1f980-9b0d-4f63-a70d-fd366658f863 | 2024-12-26 | Warnings | M012 |
| OXYMETAZOLINE HYDROCHLORIDE | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC. | 2ee2b332-9b85-45a6-b242-3f0ebfbd08a6 | 2024-12-26 | Warnings | M012 |
| OXYMETAZOLINE HYDROCHLORIDE | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | aebc7cf8-aaf7-4746-89f5-a64d0be1641e | 2024-12-26 | Warnings | M012 |
| Foster and Thrive Chest Congestion Relief | GUAIFENESIN | Strategic Sourcing Services LLC | a1661a66-5e8c-4144-9c82-cbbcc75fb222 | 2024-12-23 | Warnings | M012 |
| Geri Dryl | DIPHENHYDRAMINE HCL | GERI-CARE PHARMACEUTICALS, CORP | 34d36146-6827-4800-8483-c0edb8f4cc28 | 2024-12-23 | Warnings | M012 |
| Guaiasorb DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 6299e352-116e-43f2-b40f-c704a7bd5d61 | 2024-12-23 | Warnings | M012 |
| Equaline Chest Congestion Relief | GUAIFENESIN | United Natural Foods, Inc. dba UNFI | ad9fde8b-10cd-4778-917d-1ed6b67e5ab1 | 2024-12-23 | Warnings | M012 |
| Equaline Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | United Natural Foods, Inc. dba UNFI | a40f5893-eb96-4e0e-b965-d78293c48dc9 | 2024-12-23 | Warnings | M012 |
| Tukol X-Pecto Miel Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA, Inc. | b9d32964-5bd7-44b0-be98-827d5310ed4f | 2024-12-20 | Warnings | M012 |
| Halls Honey Vanilla | MENTHOL | Mondelez Global LLC | 8e94a1b8-8915-4595-b097-8a0a319d54aa | 2024-12-20 | Warnings | M012 |
| Halls Sugar Free Mentho-Lyptus | MENTHOL | Mondelez Global LLC | 96046858-c57b-426e-8279-91b35e05bcdb | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, Best Choice | LEVMETAMFETAMINE | Valu Merchandisers Company | 3f1c086c-bc22-4abb-9921-565a13f30c20 | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler | LEVMETAMFETAMINE NASAL DECONGESTANT | Walgreens | 77924474-ccc7-497b-9168-91490bcfadfc | 2024-12-20 | 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 |