Nighttime Cold and Flu Multi Symptom Relief
- Product NDC
- 83059-0177
- 11-digit product format
- 830590177
- Labeler code
- 83059
- Product ID
- 83059-0177_5a876754-01fb-f5dd-e063-6294a90a8208
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Shield Pharmaceuticals Corp
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-09-02
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325; 15; 6.25 mg/1; mg/1; mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- 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
- Nighttime Cold and Flu Multi Symptom Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1094549 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| decafa3a-3734-4161-bab0-121945881846 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Dr Kids Pain and Fever | ACETAMINOPHEN | CalmCo LLC | 2ee6df99-727a-34c6-e063-6294a90a6bbc | 2026-07-06 | Warnings | M012 |
| Dr Kids Allergy Relief | DIPHENHYDRAMINE HCL | CalmCo LLC | 28ec213e-fabb-28ec-e063-6394a90ad102 | 2026-07-06 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Select Consumer Group | 55fc7d6f-cc44-b4c0-e063-6294a90ae4fc | 2026-07-06 | Warnings | M012 |
| Allergy Plus Sinus Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL | DOLGENCORP, LLC | f2eacb1b-8b29-41ec-828a-c1f902ac0934 | 2026-07-06 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Select Consumer Group | 55d10292-e673-9896-e063-6294a90a5674 | 2026-07-04 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Select Consumer Group | 55bddbea-5ad9-6a18-e063-6394a90a461d | 2026-07-03 | Warnings | M012 |
| CONTAC COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | VESPYR BRANDS LLC | f72d510b-e370-4137-8d4f-d9afd5d19a19 | 2026-07-03 | Warnings | M012 |
| Nite time Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | f8f84be1-e3b1-4e93-8e1c-ee93e1f4af13 | 2026-07-02 | Warnings | M012 |
| COUGH AND CHEST CONGESTION | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Meijer, Inc. | 9d355bf8-6398-4f3a-902a-c41cf5840c15 | 2026-07-02 | Warnings | M012 |
| TUSSIN CF SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amazon.com Services LLC | 01d6c897-619d-4a6d-8950-4d6d32346b9b | 2026-07-01 | Warnings | M012 |
| NITE TIME INTENSE FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 161c34b4-3cd2-40b4-b13e-ad980ad4249c | 2026-07-01 | Warnings | M012 |
| Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 437cd589-f5da-4390-b178-609d4537eaab | 2026-07-01 | Warnings | M012 |
| Cold and Flu Nighttime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 9167a80e-fcf0-4b64-97e6-8a8ac566f134 | 2026-06-29 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS CHERRY | DISCOUNT DRUG MART | 55653790-9400-e63b-e063-6394a90ae5f7 | 2026-06-29 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS MENTHOL | DISCOUNT DRUG MART | 55656a74-9721-62cf-e063-6394a90a7eb7 | 2026-06-29 | Warnings | M012 |
| MGC Health | COUGH DROPS CHERRY | Medical Group Care LLC | 5565f02b-ce38-339f-e063-6294a90a671c | 2026-06-29 | Warnings | M012 |
| DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Meijer, Inc. | b3be2068-39e8-45f8-950e-afaee2c2520f | 2026-06-29 | Warnings | M012 |
| NIGHTTIME COUGH DM | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 646f65f4-b9e4-4291-aadc-d2070848d35c | 2026-06-29 | Warnings | M012 |
| Sinus Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | DOLGENCORP, LLC | 259b6f12-50c0-4e7a-9a44-bdf7e9a20a56 | 2026-06-29 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Health Pharma USA LLC | 31755678-825c-b84a-e063-6294a90a5a83 | 2026-06-27 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83059-0177-1 | 83059017701 | 1 BLISTER PACK in 1 CARTON (83059-0177-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2026-09-02 | No | No | Current |