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 |
|---|---|---|---|---|---|---|
| equaline nasal | OXYMETAZOLINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 07e0328e-1912-4f25-9e1e-9482d4665be0 | 2024-09-07 | Warnings | M012 |
| Benadryl Allergy EXTRA STRENGTH | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | dd0a8069-18d8-5696-e053-2995a90a2f22 | 2024-09-06 | Warnings | M012 |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | PAI Holdings, LLC | 88d0994c-4270-4408-8837-bd97510b2118 | 2024-09-06 | Warnings | M012 |
| QCH Maximum Strength Mucus Relief 617 | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Chain Drug Marketing Association Inc. | a1c5c15e-0f3a-47d3-b9ed-1e0018417514 | 2024-09-06 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime Soft Chews | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 6ba64bbe-7599-406a-9187-737c0f8c1c2a | 2024-09-05 | Warnings | M012 |
| Cough Relief Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | 344282fc-3bd1-4f49-9bd1-08c5a58d1f73 | 2024-09-05 | Warnings | M012 |
| Equate Nasal | PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 95ef1819-edc3-4dda-8514-85b61538cc72 | 2024-09-04 | Warnings | M012 |
| Up and up nasal | OXYMETAZOLINE HYDROCHLORIDE | Target Corporation | 0c246c11-eadd-4ac6-bd58-5fdb151e06d6 | 2024-09-04 | Warnings | M012 |
| Exchange Select Nasal | OXYMETAZOLINE HYDROCHLORIDE | Army & Air Force Exchange Service | aafa9163-f08e-48c9-9ca1-7b72f67d007d | 2024-08-31 | Warnings | M012 |
| nasal 12 hour | OXYMETAZOLINE HYDROCHLORIDE | Meijer Distribution Inc | e9ee03db-a070-4c2b-ac61-7fd22bab2795 | 2024-08-31 | Warnings | M012 |
| dg health nasal | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | 42b58928-e8e5-49e4-b49e-498d77d64fcd | 2024-08-28 | Warnings | M012 |
| nasal mist | OXYMETAZOLINE HCL | CVS Pharmacy | b71c557a-eb93-40d1-87c4-847f5468fc1e | 2024-08-28 | Warnings | M012 |
| nasal | OXYMETAZOLINE HCL | Kroger Company | 0a24d98a-5950-49de-8b77-ea880b08d2c5 | 2024-08-28 | Warnings | M012 |
| basic care no drip nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | 96e018e2-e0b5-4802-a4a1-73a73d574082 | 2024-08-28 | Warnings | M012 |
| Topcare Nasal | OXYMETAZOLINE HCL | Topco Associates LLC | b5434599-5485-4949-9d76-b1ef3ad17c1a | 2024-08-28 | Warnings | M012 |
| basic care no drip nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | b15eb271-7842-495b-aa0f-9b20def86dc1 | 2024-08-28 | Warnings | M012 |
| Topcare Nasal | OXYMETAZOLINE HYDROCHLORIDE | Topco Associates LLC | f1dd78e0-f700-4469-85d6-18cc299e8746 | 2024-08-28 | Warnings | M012 |
| equaline nasal | OXYMETAZOLINE HCL | United Natural Foods, Inc. dba UNFI | 69308693-a094-42a9-a041-e73647a25cc1 | 2024-08-27 | Warnings | M012 |
| signature care nasal decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | f9ac80d1-3753-412b-a407-18a6b50e5d1c | 2024-08-27 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 20ac6010-84f4-eeff-e063-6294a90a50a7 | 2024-08-27 | 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 |