Medique Decorel Forte
- Product NDC
- 47682-435
- 11-digit product format
- 476820435
- Labeler code
- 47682
- Product ID
- 47682-435_3e4fe7f8-b07f-5ac2-e063-6394a90afc08
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unifirst First Aid Corporation
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-09-26
- Substance
- PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 5; 325; 10; 100 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- 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
- Medique Decorel Forte
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04JA59TNSJ | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1098435 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e64c283b-0efa-0bfd-e053-2a95a90ab71d | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47682-435-36 | Medique Decorel Forte | 75 in 1 BOX | TABLET, FILM COATED | 75 | 5 | |
| 47682-435-80 | Medique Decorel Forte | 40 in 1 BOX | TABLET, FILM COATED | 40 | 5 | |
| 47682-435-99 | Medique Decorel Forte | 2 in 1 PACKET | TABLET, FILM COATED | 2 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 47682-435 | MEDIQUE DECOREL FORTE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED MEDI-FIRST COUGH COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED MEDI-FIRST PLUS COUGH COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240915_e64c283b-0efa-0bfd-e053-2a95a90ab71d.zip |
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 |
|---|---|---|---|---|---|---|
| G-Supress DX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | 5dd44337-f3aa-4e73-a206-4a29850a2f7c | 2025-11-12 | Warnings | M012 |
| Allergy Relief Complete | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | 15b3de6c-7ccc-408b-8789-d0e2f21a8835 | 2025-11-12 | Warnings | M012 |
| PRESGEN PEDIATRIC | GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE | KRAMER NOVIS | 12fb91e5-6059-4b3a-a2de-762aa51a25b7 | 2025-11-12 | Warnings | M012 |
| Sorbugen | DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE | Kramer Novis | a8f2a2d7-0360-45a8-9635-c852f4a7d7ba | 2025-11-12 | Warnings | M012 |
| DESGEN DM | DEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCL | Kramer Novis | 6ab47174-e1fd-47ce-8788-06b7cdad5218 | 2025-11-12 | Warnings | M012 |
| Presgen | GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Kramer Novis | edad7a86-0d27-4a98-85b2-4b6725904f28 | 2025-11-12 | Warnings | M012 |
| TUSSI PRES PEDIATRIC | GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE | KRAMER NOVIS | b01a45df-3cea-4729-80c1-7f35b7f707f0 | 2025-11-12 | Warnings | M012 |
| TUSICOF | DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE | Kramer Novis | e966b75c-4bb4-4216-8247-baada8f5d759 | 2025-11-12 | Warnings | M012 |
| Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 52327ed0-ea49-4d1c-b928-20ab381be9f2 | 2025-11-11 | Warnings | M012 |
| TOPCO Childrens Cough Relief | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Topco Associates, LLC | ee0f5627-5104-4990-88ee-2fb46965bc1e | 2025-11-11 | Warnings | M012 |
| TOPCARE Childrens Cold and Cough and Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates, LLC | 8931d4ca-c599-49be-87e1-8c0598f38b77 | 2025-11-11 | Warnings | M012 |
| TOPCARE Multi Symptom Flu Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Topco Associates, LLC | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2025-11-11 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 2025-11-11 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435e6387-1ee0-c20f-e063-6294a90adac5 | 2025-11-11 | Warnings | M012 |
| Buscapina | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | OPMX LLC | 10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b | 2025-11-10 | Warnings | M012 |
| TOPCARE Childrens Allergy Chews | DIPHENHYDRAMINE HCL | Topco Associates, LLC | b5e15dd1-6e99-411c-9183-8a4265eae404 | 2025-11-08 | Warnings | M012 |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | 103de130-ef12-4c58-bbcf-234b3f3b2cbf | 2025-11-08 | Warnings | M012 |
| Cough Drops Dollar General Strawberry 30ct | MENTHOL | Dollar General Corporation | 2b3fbab9-92b5-42a7-b27b-ff46350ce055 | 2025-11-07 | Warnings | M012 |
| Robitussin Day and Night Maximum Strength Cough DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 2025-11-07 | Warnings | M012 |
| Allergy plus Sinus Headache | ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG | Shield Pharmaceuticals Corp | 093649a4-f968-49bd-83af-bb7e0f448ecf | 2025-11-07 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1098435 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | e64c283b-0efa-0bfd-e053-2a95a90ab71d | 5 |
| 1098435 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | e64c283b-0efa-0bfd-e053-2a95a90ab71d | 5 |
| 1098435 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | e64c283b-0efa-0bfd-e053-2a95a90ab71d | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 47682-435-36 | 47682043536 | 75 PACKET in 1 BOX (47682-435-36) / 2 TABLET, FILM COATED in 1 PACKET (47682-435-99) | 75 packet | 2022-12-12 | 0000-00-00 | No | No | Current |
| 47682-435-80 | 47682043580 | 40 PACKET in 1 BOX (47682-435-80) / 2 TABLET, FILM COATED in 1 PACKET (47682-435-99) | 40 packet | 2022-09-26 | 0000-00-00 | No | No | Current |
| 47682-435-99 | 47682043599 | 2 TABLET, FILM COATED in 1 PACKET (47682-435-99) | 2022-09-26 | No | No | Current |