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 |
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | 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 |
|---|---|---|---|---|---|---|
| Daytime Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN,/ ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORP | 0b1e230d-4354-bf61-e063-6394a90a2b2f | 2023-12-09 | Warnings | M012 |
| Phenylephrine HCl Maximum Strength | PHENYLEPHRINE HCL | A-S Medication Solutions | fcb769d0-aa45-48eb-acd0-2247b392f9fe | 2023-12-09 | Warnings | M012 |
| Daytime and Nighttime Severe Honey Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0bf915af-a016-0a46-e063-6394a90aacf5 | 2023-12-08 | Warnings | M012 |
| Maximum Strength Daytime Severe and Nighttime Cold and Flu | DAYTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, NIGHTTIME - ACETAMINOPHEN, DIPHENHYDRAMINE HCI | TARGET Corporation | 0bf9c0df-7676-3060-e063-6394a90a16c7 | 2023-12-08 | Warnings | M012 |
| Nazal | NAPHAZOLINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | 4d4043f8-5ed3-4027-beb6-687db1308202 | 2023-12-06 | Warnings | M012 |
| Family Wellness Oxymetazoline | OXYMETAZOLINE | FAMILY DOLLAR (Family Wellness) | 8b4557d4-74a0-400f-ad7a-6d31473b3c67 | 2023-12-06 | Warnings | M012 |
| Childrens Plus Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 1598e6f8-08ee-4216-a5ab-76cad37b09a7 | 2023-12-06 | Warnings | M012 |
| Welmedix HomeCare PRO Fragile Skin Protectant | PETROLATUM | Welmedix LLC | 6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf | 2023-12-05 | Warnings | M012 |
| Welmedix HomeCare PRO Extra Strength Rapid Rash Relief | PETROLATUM, ZINC OXIDE | Welmedix LLC | 551e6cce-7adc-4e98-baff-2703b83d7526 | 2023-12-05 | Warnings | M012 |
| Stona-S | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | 2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1 | 2023-12-04 | Warnings | M012 |
| Stona Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | afc95c82-18da-487b-b4bb-51e0be0378da | 2023-12-04 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | Walgreens Company | a14643a1-3d91-491a-88d6-22dccde97938 | 2023-12-04 | Warnings | M012 |
| TopCare Day Time SEVERE Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 14d53907-a4a2-4a0f-b2d6-33474945f9e1 | 2023-12-04 | Warnings | M012 |
| Banophen | DIPHENHYDRAMINE HCL | Proficient Rx LP | 62934d0f-b23d-4c03-9d60-a7bad41f9b42 | 2023-12-01 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Proficient Rx LP | b1c849e5-8003-4fd3-811d-6a927523e353 | 2023-12-01 | Warnings | M012 |
| Akin Expectorant Formula Strawberry Banana | GUAIFENESIN | Southern Sales & Service, Inc. | b63b0133-d2da-432b-a154-9e77535bbef9 | 2023-11-29 | Warnings | M012 |
| Akin Cough Formula DM Strawberry Banana | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Southern Sales & Service, Inc. | 7a81efd8-775d-455e-860f-f3e3b369a0a7 | 2023-11-29 | Warnings | M012 |
| Akin | GUAIFENESIN | Southern Sales & Service, Inc. | bb2c9f21-6765-4286-bd71-de01cdf4c4e9 | 2023-11-29 | Warnings | M012 |
| Akin Cough Formula DM | DEXTROMETHORPHAN, GUAIFENESIN | Southern Sales & Service, Inc. | 1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a | 2023-11-29 | Warnings | M012 |
| diphenhydramine hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Simpex Pharma Pvt. Ltd | 82771f6a-8b3d-4ffa-8b35-09c2faf3582c | 2023-11-29 | 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 |