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 |
|---|---|---|---|---|---|---|
| THERAFLU NIGHTTIME SEVERE COLD AND COUGH | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 5f7f6f70-0f36-4541-89f2-d953259cdb1e | 2024-01-28 | Warnings | M012 |
| RESFRIOL D | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | 0e9c96b9-41ac-0faf-e063-6294a90a8ab5 | 2024-01-26 | Warnings | M012 |
| Allergy Relief | ALLERGY RELIEF | Good Sense | bb709377-7bb3-4931-a2b6-2443aee07c12 | 2024-01-26 | Warnings | M012 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 721bfee2-0d3d-4d8b-beee-1ea83064d1c8 | 2024-01-23 | Warnings | M012 |
| Sugar Free Cough Drops Honey Lemon | MENTHOL | Cardinal Health 110, Inc. | fe90dc33-2815-8296-e053-6294a90ac1df | 2024-01-19 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Cardinal Health 110, Inc. | fe91543e-a798-6399-e053-6394a90af5e5 | 2024-01-19 | Warnings | M012 |
| Sugar Free Cough Drops Black Cherry | MENTHOL | Cardinal Health 110, Inc. | fe90cf63-d286-fa5e-e053-6394a90a7759 | 2024-01-19 | Warnings | M012 |
| Cough Drops Menthol Honey Lemon | COUGH DROPS MENTHOL | Cardinal Health 110, Inc. | fe5b3f6d-2a2d-f322-e053-6394a90aba04 | 2024-01-19 | Warnings | M012 |
| Cough Drops Menthol | MENTHOL COUGH DROPS | Cardinal Health 110, Inc. | fe5b557e-a689-a32c-e053-6294a90aadbd | 2024-01-19 | Warnings | M012 |
| Cough Drops Cherry | CHERRY FLAVOR COUGH DROPS | Cardinal Health 110, Inc. | fe5b5e57-1368-c62b-e053-6294a90ae82c | 2024-01-19 | Warnings | M012 |
| Leader Zinc Oxide | ZINC OXIDE | Cardinal Health 110,Inc. | 4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1 | 2024-01-18 | Warnings | M012 |
| Cough and Congestion DM Sugar Free | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Best Choice (Valu Merchandisers Company) | 4656e60e-4733-45c1-bf55-d156e45085c6 | 2024-01-17 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | Rugby Laboratories | 775f97c0-6f82-49a8-82ac-f1a73920c3ec | 2024-01-11 | Warnings | M012 |
| SinuFrin NeilMed | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals Inc | f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae | 2024-01-11 | Warnings | M012 |
| SinuFrin Plus NeilMed | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals, Inc. | 99afe6a6-1350-49c6-9347-b7e531e35925 | 2024-01-11 | Warnings | M012 |
| Childrens Tukol Multi-Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA, Inc. | 85fe6f0f-41c8-44d3-a34a-355938da5f72 | 2024-01-11 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 110, LLC. DBA Leader | ad437177-08eb-4811-883f-ac543d5bc58c | 2024-01-11 | Warnings | M012 |
| Allergy Antihistamine | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | af5053d8-ba02-4cdf-877f-8c1e368dafe0 | 2024-01-10 | Warnings | M012 |
| HISTEX | TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | cc466d33-cf3e-4f1c-a794-6d3d79903adf | 2024-01-08 | Warnings | M012 |
| HISTEX-DM | DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | 836d062c-29f0-4fd7-b65c-771a3bbd52c4 | 2024-01-08 | 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 |