Nighttime Severe Cold and Flu Maximum Strength mini softgels
- Product NDC
- 83059-0074
- 11-digit product format
- 830590074
- Labeler code
- 83059
- Product ID
- 83059-0074_59fbe7e7-a706-d6a7-e063-6394a90a472e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Shield Pharmaceuticals Corp
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-08-26
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
- 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 Severe Cold and Flu Maximum Strength mini softgels
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1297288 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 70c5517d-be4e-4317-b4f4-df660c71c699 | 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 |
|---|---|---|---|---|---|---|
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | 07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a | 2024-05-01 | Warnings | M012 |
| Night Time Cold and Flu Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | dbfb8971-a122-4a97-a665-e3f0d494876e | 2024-05-01 | Warnings | M012 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | P & L Development, LLC | c08b150c-d821-466c-8521-f77535d6af1e | 2024-04-30 | Warnings | M012 |
| childrens allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreen Company | 7848bb09-2af8-47f6-b32d-96635a750a55 | 2024-04-29 | Warnings | M012 |
| NASAL and SINUS DECONGESTANT | PHENYLEPHRINE HYDROCHLORIDE | JHK Inc dba American Safety & First Aid | 63e51305-2575-49c4-9fda-7b3e1b4b6ede | 2024-04-26 | Warnings | M012 |
| Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Haleon US Holdings LLC | 7decc168-e847-4bbe-910b-26081469406f | 2024-04-26 | Warnings | M012 |
| Severe cold and flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI | P & L Development, LLC | 7c92bdcf-db1f-4299-982f-6a3da9cba6e6 | 2024-04-25 | Warnings | M012 |
| Severe cold and flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI | P & L Development, LLC | 15727e06-7bfc-424e-9e68-cc9cd5695bfd | 2024-04-25 | Warnings | M012 |
| Severe Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | P & L Development, LLC | 5872fed8-862b-44a2-a06e-51ebf8618271 | 2024-04-25 | Warnings | M012 |
| CHERRY COUGH DROPS 50CT | MENTHOL, UNSPECIFIED FORM | JHK Inc dba American Safety & First Aid | 2f54b9c1-3a37-48fd-b964-6aa2631b8e62 | 2024-04-24 | Warnings | M012 |
| Dye Free Allergy childrens | DIPHENHYDRAMINE HYDROCHLORIDE | QUALITY CHOICE (Chain Drug Marketing Association) | f1a33c2f-2330-43f3-8026-de21808aec66 | 2024-04-22 | Warnings | M012 |
| Cold and Flu Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | fc7954a6-d061-4160-b1d1-a19eb9eabff4 | 2024-04-22 | Warnings | M012 |
| Dibromm Cold and Allergy Childrens | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | ea285d5a-9eb4-4f71-bb1b-4e24a8972819 | 2024-04-22 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | c573da1e-c7ca-46e6-ad42-4ded2547afc3 | 2024-04-22 | Warnings | M012 |
| Cough Relief Cough Suppressant | DEXTROMETHORPHAN HBR | QUALITY CHOICE (Chain Drug Marketing Association) | 13ae4c67-a3fe-440c-91b8-c9412626c3cd | 2024-04-22 | Warnings | M012 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 47660794-22cc-4863-a183-e694d27e3543 | 2024-04-19 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | f9c08b18-a119-406b-bd96-73572b4445e2 | 2024-04-18 | Warnings | M012 |
| Nighttime Cough Relief | DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | e1fa0f51-6a68-4f6f-8988-0949d1942c2f | 2024-04-18 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | 025f6622-a6db-4a5c-aebd-5d54172fa4a1 | 2024-04-18 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | f9530d55-8226-4659-84f0-2c0b411572be | 2024-04-17 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83059-0074-1 | 83059007401 | 1 BLISTER PACK in 1 CARTON (83059-0074-1) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2026-08-26 | No | No | Current |