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
- 2026-12-31
- 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
- 2026-12-31
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 |
|---|---|---|---|---|---|---|
| good sense allergy | DIPHENHYDRAMINE HCL | L. Perrigo Company | bf5039a0-2109-41a2-84a9-b5167d0a93da | 2026-07-22 | Warnings | M012 |
| Congestion and Headache | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 432c3ec4-7595-4213-94e3-ce41af91804e | 2026-07-21 | Warnings | M012 |
| SKAPEMED ORIGINAL NASAL | NAPHAZOLINE HCL 0.05% ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a208a1f-f6e8-0b4a-e063-6294a90a10c8 | 2026-07-21 | Warnings | M012 |
| SERYNTH FAST RELIEF NASAL | NAPHAZOLINE HCL 0.05% FAST RELIEF NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4abdc0-aded-1b8a-e063-6394a90a9b56 | 2026-07-21 | Warnings | M012 |
| DERMFREE ORIGINAL NASAL | NAPHAZOLINE HCL0.05%ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4d0c03-7d8f-76cb-e063-6394a90a938c | 2026-07-21 | Warnings | M012 |
| DERMFREE ORIGINAL NASAL | NAPHAZOLINE HCL 0.05%ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4d3a2b-a4ed-c736-e063-6394a90a96df | 2026-07-21 | Warnings | M012 |
| Severe Cough and Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 791eaac1-ddb5-40e2-9040-52dfadc30e06 | 2026-07-21 | Warnings | M012 |
| DRx Choice DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Raritan Pharmaceuticals Inc. | 9ab47b10-b1ed-4ae1-94e8-09d50e952bb0 | 2026-07-21 | Warnings | M012 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | P & L Development, LLC | 17639c3b-5d36-41f5-bd0d-da29075abd09 | 2026-07-21 | Warnings | M012 |
| NATUHEAL ORIGINAL NASAL | NAPHAZOLINE HCL 0.05% ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a470b9e-c83f-fb20-e063-6294a90a2f13 | 2026-07-20 | Warnings | M012 |
| TYLENOL Cold plus Flu Multi-Symptom Liquid Gels Day | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 1c444202-19e9-8d04-e063-6394a90a9294 | 2026-07-20 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS HONEY LEMON | DISCOUNT DRUG MART | 5565a581-e2b5-81a5-e063-6394a90af409 | 2026-07-20 | Warnings | M012 |
| Best Choice Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 40e0b17a-5704-4203-8f0a-11b2fcf81f8f | 2026-07-17 | Warnings | M012 |
| Equate Daytime Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | WALMART INC. | ee1ef41d-b8be-42f3-9918-ccf1c0a80241 | 2026-07-17 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 879a7804-f3d4-4a3d-bc92-b473499d6c95 | 2026-07-17 | Warnings | M012 |
| Best Choice | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 95007785-ddf6-4386-af5f-84dac1066b40 | 2026-07-17 | Warnings | M012 |
| BEST CHOICE No Drip | ALLERGY SINUS | BEST CHOICE (VALU MERCHANDISERS COMPANY) | d5f95b56-8201-4d97-82ab-e23761bfe720 | 2026-07-17 | Warnings | M012 |
| Best Choice Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 7d19fdba-35b0-424a-ba11-315521d3256d | 2026-07-17 | Warnings | M012 |
| Best Choice Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | badb15ac-91e8-4962-96f5-beb250977560 | 2026-07-17 | Warnings | M012 |
| Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0839c07b-f692-4af1-85b8-da60fb281d49 | 2026-07-17 | 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 |