Daytime Nighttime Severe Cold and Flu Relief
- Product NDC
- 55319-138
- 11-digit product format
- 553190138
- Labeler code
- 55319
- Product ID
- 55319-138_b37874a1-68f6-4168-8880-8f5a3b7e1427
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCI Doxylamine Sucinate
- Dosage form
- KIT
- Labeler
- Family Dollar (FAMILY WELLNESS)
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-07-31
- 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
- Daytime Nighttime Severe Cold and Flu Relief
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 22918db6-9096-4eb8-a742-aaa2dd5c31da | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-138-16 | Daytime Nighttime Severe Cold and Flu Relief | 1 in 1 KIT | KIT | 1 | 7 | |
| 55319-145-08 | Daytime Nighttime Severe Cold and Flu Relief | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 mL | 10 mg in 15mL | 7 |
| 55319-641-08 | Daytime Nighttime Severe Cold and Flu Relief | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 mL | 20 mg in 30mL | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55319-138 | DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATE) KIT [FAMILY DOLLAR (FAMILY WELLNESS)] | 6 | Current NDC, 3 package rows | 20250417_22918db6-9096-4eb8-a742-aaa2dd5c31da.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 |
|---|---|---|---|---|---|---|
| SDA Laboratories Tussin | GUAIFENESIN | SDA Laboratories, Inc. | 2a444cc8-96be-9432-e063-6394a90a1b63 | 2024-12-27 | Warnings | M012 |
| SDA Laboratories Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | SDA Laboratories, Inc. | 2a445f31-818d-11b1-e063-6294a90a8cb1 | 2024-12-27 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Richmond Pharmaceuticals Inc. | f184b2aa-91a4-44f9-b688-d4e318181984 | 2024-12-26 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Richmond Pharmaceuticals, Inc. | 2792032a-ff0f-4d5f-a8e3-b8b8c54f4e99 | 2024-12-26 | Warnings | M012 |
| OXYMETAZOLINE HYDROCHLORIDE | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC. | c7b1f980-9b0d-4f63-a70d-fd366658f863 | 2024-12-26 | Warnings | M012 |
| OXYMETAZOLINE HYDROCHLORIDE | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC. | 2ee2b332-9b85-45a6-b242-3f0ebfbd08a6 | 2024-12-26 | Warnings | M012 |
| OXYMETAZOLINE HYDROCHLORIDE | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | aebc7cf8-aaf7-4746-89f5-a64d0be1641e | 2024-12-26 | Warnings | M012 |
| Foster and Thrive Chest Congestion Relief | GUAIFENESIN | Strategic Sourcing Services LLC | a1661a66-5e8c-4144-9c82-cbbcc75fb222 | 2024-12-23 | Warnings | M012 |
| Geri Dryl | DIPHENHYDRAMINE HCL | GERI-CARE PHARMACEUTICALS, CORP | 34d36146-6827-4800-8483-c0edb8f4cc28 | 2024-12-23 | Warnings | M012 |
| Guaiasorb DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 6299e352-116e-43f2-b40f-c704a7bd5d61 | 2024-12-23 | Warnings | M012 |
| Equaline Chest Congestion Relief | GUAIFENESIN | United Natural Foods, Inc. dba UNFI | ad9fde8b-10cd-4778-917d-1ed6b67e5ab1 | 2024-12-23 | Warnings | M012 |
| Equaline Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | United Natural Foods, Inc. dba UNFI | a40f5893-eb96-4e0e-b965-d78293c48dc9 | 2024-12-23 | Warnings | M012 |
| Tukol X-Pecto Miel Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA, Inc. | b9d32964-5bd7-44b0-be98-827d5310ed4f | 2024-12-20 | Warnings | M012 |
| Halls Honey Vanilla | MENTHOL | Mondelez Global LLC | 8e94a1b8-8915-4595-b097-8a0a319d54aa | 2024-12-20 | Warnings | M012 |
| Halls Sugar Free Mentho-Lyptus | MENTHOL | Mondelez Global LLC | 96046858-c57b-426e-8279-91b35e05bcdb | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, Best Choice | LEVMETAMFETAMINE | Valu Merchandisers Company | 3f1c086c-bc22-4abb-9921-565a13f30c20 | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler | LEVMETAMFETAMINE NASAL DECONGESTANT | Walgreens | 77924474-ccc7-497b-9168-91490bcfadfc | 2024-12-20 | Warnings | M012 |
| Levmetamfetamine | LEVMETAMFETAMINE | Meijer, Inc. | d11e916f-90a6-4099-bf83-75f2dfbd6266 | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, DG health | LEVMETAMFETAMINE | Dolgencorp Inc. | 5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd3 | 2024-12-20 | Warnings | M012 |
| Tukol Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA, Inc. | aef2ad43-145d-4abc-bccc-2c5fdd6882f9 | 2024-12-20 | 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55319-138-16 | 55319013816 | 1 KIT in 1 KIT (55319-138-16) * 237 mL in 1 BOTTLE, PLASTIC (55319-145-08) * 237 mL in 1 BOTTLE, PLASTIC (55319-641-08) | 1 kit | 2024-07-31 | No | No | Current |
| 55319-145-08 | 55319014508 | 237 mL in 1 BOTTLE, PLASTIC | 237 ml | Historical | |||
| 55319-641-08 | 55319064108 | 237 mL in 1 BOTTLE, PLASTIC | 237 ml | Historical |