DOLOGEN
- Product NDC
- 52083-483
- 11-digit product format
- 520830483
- Labeler code
- 52083
- Product ID
- 52083-483_19820911-7642-4293-b03e-5359d59661d6
- 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
- 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 |
|---|---|
| 656ea9ba-c9cf-44c6-af40-b8ba292ce38a | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-483-90 | 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 |
|---|---|---|---|---|---|---|
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2025-08-01 | Warnings | M012 |
| meijer Nighttime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 377248b6-d64d-8dff-e063-6394a90a43f6 | 2025-07-31 | Warnings | M012 |
| meijer Daytime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 3771f778-7ac9-7108-e063-6394a90a1105 | 2025-07-31 | Warnings | M012 |
| tussin dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS Pharmacy | 087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca | 2025-07-31 | Warnings | M012 |
| Equate Nasal | OXYMETAZOLINE HCL | Wal-Mart Stores Inc | c38a2783-aed9-466d-8976-59d03a792c04 | 2025-07-30 | Warnings | M012 |
| Quality Choice Throat Soothing Drops Creamy Strawberry | PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3b15d2ea-f784-275d-e063-6394a90a800c | 2025-07-29 | Warnings | M012 |
| Respiratory Relief | GUAIFENESIN | Schwabe North America, Inc | f683041a-4ff9-42a5-9047-a9a3140a8758 | 2025-07-29 | Warnings | M012 |
| Childrens Robitussin Honey Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | b87f700e-3414-463c-80d4-c3dbca89a488 | 2025-07-29 | Warnings | M012 |
| Tussin DM | TUSSIN DM | Allegiant Health | 7a2f8d48-3123-4c37-b238-bd7cc4242bb7 | 2025-07-23 | Warnings | M012 |
| Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | GADAL Laboratories, Inc | 5fb2438b-8f2d-4af2-9981-42d278d26800 | 2025-07-23 | Warnings | M012 |
| DR. SANA COUGH AND CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | GADAL Laboratories, Inc | baca0580-4c30-4b94-89fa-a7cf06d4ff25 | 2025-07-22 | Warnings | M012 |
| Defensol D | ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI | Menper Distributors, Inc. | f466c660-69eb-4581-81ff-1499fa421d8b | 2025-07-22 | Warnings | M012 |
| Defensol D Blister Pack | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCI | Menper Distributors, Inc. | 0dfcc977-6101-4536-e063-6294a90a7a48 | 2025-07-22 | Warnings | M012 |
| Broncofin | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Menper Distributors, Inc. | fdf67382-1692-485b-92f1-2cbb8be4fb70 | 2025-07-22 | Warnings | M012 |
| Defensol Adult Syrup | GUAIFENESIN, DEXTROMETHORPHAN HBR | Menper Distributors, Inc. | 62acff69-8c40-4a0e-8d56-be2cc14e3d45 | 2025-07-22 | Warnings | M012 |
| Cosedal Drops | DEXTROMETHORPHAN HBR, GUAIFENESIN | Menper Distributors, Inc. | 1241d249-ea3b-4d2b-87ed-835d6a2d286a | 2025-07-22 | Warnings | M012 |
| Berro y Cebolla DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Menper Distributors, Inc. | 20107bd9-6d84-4ab5-a0d9-966f1f11d919 | 2025-07-22 | Warnings | M012 |
| Defensol-ito | DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE | Menper Distributors, Inc | a7c7a60d-d49f-4239-92f7-714eac7eb0c5 | 2025-07-22 | Warnings | M012 |
| Bisolvine Children | GUAIFENESIN, DEXTROMETHORPHAN | MENPER DISTRIBUTORS INC. | 896a5443-e3d2-4af7-9e27-f1c1899ce038 | 2025-07-22 | Warnings | M012 |
| Bisolvine Aloe-Miel | DEXTROMETHORPHAN, GUAIFENESIN | MENPER DISTRIBUTORS INC. | 34801c79-ce88-492f-808e-b639e8601607 | 2025-07-22 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2729424 | acetaminophen 500 MG / dexbrompheniramine maleate 2 MG Oral Tablet | PSN | 656ea9ba-c9cf-44c6-af40-b8ba292ce38a | 1 |
| 2729424 | acetaminophen 500 MG / dexbrompheniramine maleate 2 MG Oral Tablet | SCD | 656ea9ba-c9cf-44c6-af40-b8ba292ce38a | 1 |
| 2729424 | APAP 500 MG / dexbrompheniramine maleate 2 MG Oral Tablet | SY | 656ea9ba-c9cf-44c6-af40-b8ba292ce38a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52083-483-90 | 52083048390 | 90 TABLET in 1 BOTTLE, PLASTIC (52083-483-90) | 90 tablet | 2025-12-15 | No | No | Current |