Flu Relief Therapy
- Product NDC
- 36800-317
- 11-digit product format
- 368000317
- Labeler code
- 36800
- Product ID
- 36800-317_50a1e4d6-f99d-4f7f-877e-f26803460704
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- TOP CARE (Topco Associates LLC)
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-08-31
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 25; 10 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 36800-317 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 36800-317 | 36800-317-08 | D | Discontinued by firm | 2026-08-17 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-317-08 | Flu Relief TherapyNighttime | 245 mL in 1 BOTTLE, PLASTIC | LIQUID | 245 | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-317 | FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)] | 5 | Current NDC, Legacy NDC, 1 package rows | 20231014_ed063755-6bdc-479a-92ab-04120350434d.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 |
|---|---|---|---|---|---|---|
| Sleep Aid NightTime | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 4fff664b-4ff0-4007-95ab-cb273807b9b4 | 2026-08-25 | Warnings | M012 |
| Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | 464534ee-15f8-3af8-e063-6394a90a3f18 | 2026-08-24 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 7d972559-6184-476b-9cbf-1bc5663ea00d | 2026-08-24 | Warnings | M012 |
| DG HEALTH MULTI SYMPTOM SEVERE COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, LLC | 47ddbb0d-0823-4817-9c56-e7fff77d601c | 2026-08-21 | Warnings | M012 |
| Mucus Relief DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | DOLGENCORP, LLC | 5be4e730-3cd6-414e-a23b-f6cad8088750 | 2026-08-21 | Warnings | M012 |
| Mucus Relief DM Cough Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | 6304a581-9238-4539-b157-293fc05c173e | 2026-08-21 | Warnings | M012 |
| Afrin Original Nasal | OXYMETAZOLINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc. | ecfa14b8-a3f3-4569-b489-c9e1a51cf09e | 2026-08-20 | Warnings | M012 |
| CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK | BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL | CVS PHARMACY, INC. | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2026-08-19 | Warnings | M012 |
| CVS Adult Mucus chest congestion | GUAIFENESIN | CVS PHARMACY | bec04049-03b2-4465-9cf5-0ad2ef8014ef | 2026-08-19 | Warnings | M012 |
| CVS Childrens Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | CVS PHARMACY, INC | fe12f3bd-3237-42d1-aec5-c831b9637175 | 2026-08-19 | Warnings | M012 |
| CVS Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY, INC | bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9 | 2026-08-19 | Warnings | M012 |
| CVS Long Acting Cough | DEXTROMETHORPHAN HBR | CVS PHARMACY, INC | 31a7c0e2-af1c-45dd-8a93-e0879cae6005 | 2026-08-19 | Warnings | M012 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | b3baf939-a9fd-47ac-9bc7-68435e32ea1e | 2026-08-19 | Warnings | M012 |
| Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS PHARMACY | 5151127a-4d09-413a-a08b-f76fb77e1188 | 2026-08-19 | Warnings | M012 |
| CVS DT and NT Combo Pack Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | CVS PHARMACY | 360c8c62-0945-4031-b291-d40c4270b940 | 2026-08-19 | Warnings | M012 |
| equate childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | WALMART INC. | 24758ab0-ba08-4b4a-9861-449612bdb89c | 2026-08-19 | Warnings | M012 |
| CVS Adult Mucus plus Chest Congestion | GUAIFENESIN | CVS PHARMACY | 3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a | 2026-08-19 | Warnings | M012 |
| CVS Childrens Cold plus Cough plus Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | CVS | 7dc30e46-e289-40fc-b217-b123fee5daee | 2026-08-19 | Warnings | M012 |
| CVS ADULT COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | CVS PHARMACY | 4490a7e1-d5b9-459c-8751-c24486807981 | 2026-08-19 | Warnings | M012 |
| CVS DayTime and NightTime Value Pack Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | CVS PHARMACY | 4c813cd5-2c97-4fc3-926c-1a0396551a31 | 2026-08-19 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-317-08 | 36800031708 | 245 mL in 1 BOTTLE, PLASTIC (36800-317-08) | 245 ml | 2015-08-31 | 0000-00-00 | No | No | Current |