Severe Nighttime Cold and Flu Relief
- Product NDC
- 55319-641
- 11-digit product format
- 553190641
- Labeler code
- 55319
- Product ID
- 55319-641_b135042b-47eb-4018-8fdb-6e1b7d5a214c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen Dextromethorphan HBr Doxylamine Succinate Phenylephrine HCI
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Family Dollar (FAMILY WELLNESS)
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-07-31
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
- 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
- Severe Nighttime Cold and Flu Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
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 |
|---|---|
| 1431245 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e5c90d6e-70aa-4886-bc81-293e0dcf5638 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-641-08 | Daytime Nighttime Severe Cold and Flu Relief | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 mL | 20 mg in 30mL | 7 |
| 55319-641-08 | Severe Nighttime Cold and Flu Relief | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55319-641 | DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATE) KIT [FAMILY DOLLAR (FAMILY WELLNESS)] | 6 | Current NDC | 20250417_22918db6-9096-4eb8-a742-aaa2dd5c31da.zip |
| 55319-641 | SEVERE NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCI) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] | 2 | Current NDC, 1 package rows | 20240731_e5c90d6e-70aa-4886-bc81-293e0dcf5638.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 |
|---|---|---|---|---|---|---|
| Menthol Cough Drops | MENTHOL | Target Corporation Inc. | eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a | 2025-01-26 | Warnings | M012 |
| Walgreens Menthol Cough Drops | MENTHOL | Walgreens | 2c62f690-8dfb-d28e-e063-6394a90a45a2 | 2025-01-23 | Warnings | M012 |
| Walgreens Cherry Cough Drops | MENTHOL | Walgreens | 2c65d836-e724-50d6-e063-6394a90a0827 | 2025-01-23 | Warnings | M012 |
| Walgreens Honey Lemon Cough Drops | MENTHOL | Walgreens | 2c67424c-2fb0-cc15-e063-6394a90a02ca | 2025-01-23 | Warnings | M012 |
| Pharmacys Prescription Analgesic Gel | MENTHOL | American Consumer Products Corp | 6f0725f2-833f-f3a0-e053-2a91aa0a3911 | 2025-01-23 | Warnings | M012 |
| Pharmacys Prescription Vapor Rub | MENTHOL | American Consumer Products Corp | 6ef328ff-f5c3-515d-e053-2a91aa0a32d3 | 2025-01-23 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Best Choice | 0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d | 2025-01-22 | Warnings | M012 |
| GOOD REMEDIES Allergy Relief SOFTGEL | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 26a02737-2cfd-769f-e063-6394a90af352 | 2025-01-22 | Warnings | M012 |
| Pharbechlor | CHLORPHENIRAMINE MALEATE 4MG | Ulai Health LLC | 6a1a5cef-e946-4ba8-9402-557c6adf45f9 | 2025-01-20 | Warnings | M012 |
| Pharbinex | GUAIFENESIN 400MG | Ulai Health LLC | 4eafa81a-aeee-4c97-85d6-594902b10919 | 2025-01-20 | M012 | |
| Pharbinex-PE | GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG | Ulai Health LLC | e459bb83-b1d6-42fc-aa46-99ad117e6144 | 2025-01-20 | M012 | |
| Pharbinex-DM | GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG | Ulai Health LLC | af80d10e-3fb2-405a-a803-1f876b8dcd10 | 2025-01-20 | M012 | |
| Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Bayer HealthCare LLC. | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 2025-01-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a23a6db6-4585-2882-e053-2a95a90ab01a | 2025-01-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold Night PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | fc754dff-cecd-fc6b-e053-6394a90ab371 | 2025-01-17 | Warnings | M012 |
| Kroger DayTime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | The Kroger Co. | 2499210b-c162-76b9-e063-6294a90adbc3 | 2025-01-17 | Warnings | M012 |
| Childrens Multi Symptom Cold Very Berry | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS | 2a849ae9-338f-4642-e063-6394a90a1ca4 | 2025-01-17 | Warnings | M012 |
| Kroger NightTime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | The Kroger Co. | 24a73de3-e9eb-4cd4-e063-6394a90aa263 | 2025-01-17 | Warnings | M012 |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HCL ORAL | Everpharm LLC | d7aaf874-69ac-49cf-93be-6d4a38b9a557 | 2025-01-16 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | 204a7fc4-142d-45fd-8a77-0612857132be | 2025-01-16 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2637731 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack | GPCK | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack | PSN | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1369842 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1369842 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 4 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 4 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 4 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 4 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55319-641-08 | 55319064108 | 237 mL in 1 BOTTLE, PLASTIC (55319-641-08) | 237 ml | 2024-07-31 | No | No | Current |