NDC 51316-919 - Daytime Cold and Cough Nighttime Cold and Congestion
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 51316-919
- Package NDCs from labels
- 51316-919-03
- Manufacturer
- CVS | Guardian Drug Company
- Effective date
- 2026-03-16
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Childrens Daytime Cold and cough - CVS | Guardian Drug Company | CVS | Guardian Drug Company | 2026-03-16 | Human OTC Drug Label |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-919-03 | Daytime Cold and Cough Nighttime Cold and Congestion | 118 mL in 1 BOTTLE | LIQUID | 118 mL | 6.25 mg in 5mL | 3 |
| 51316-919-03 | Daytime Cold and Cough Nighttime Cold and Congestion | 1 in 1 CARTON | LIQUID | 6.25 mg in 5mL | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-919 | DAYTIME COLD AND COUGH NIGHTTIME COLD AND CONGESTION (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [CVS] | 2 | Unmatched | 20250206_2cf361eb-6055-2364-e063-6294a90a69a1.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 |
|---|---|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | HF Acquisition Co. LLC, DBA Health First | 738f2ce3-520c-b3a2-e053-2a91aa0af324 | 2024-02-22 | Warnings, Adverse reactions | TC2D6JAD40 |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c600fe14-40b6-2b5a-e053-2a95a90aff98 | 2024-02-22 | Warnings, Adverse reactions | 04JA59TNSJ |
| PHENYLEPHRINE HCI | PHENYLEPHRINE HCI | HF Acquisition Co LLC, DBA HealthFirst | 7602fb73-3ce3-5978-e053-2991aa0abea3 | 2024-02-22 | Warnings, Adverse reactions | 04JA59TNSJ |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | BJWC (Berkley & Jensen / BJ's) | b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86 | 2024-02-22 | Warnings | TC2D6JAD40 |
| GI Drainage | CINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOS | Deseret Biologicals, Inc. | ff81e3ca-2f88-4daf-a734-083107269d3a | 2024-02-21 | Warnings | 059QF0KO0R |
| Nasal Spray, 24-7 for Life | OXYMETAZOLINE HYDROCHLORIDE 0.05% | Lil' Drug Store Products, Inc. | 11d27c75-fd95-f9da-e063-6394a90ac6b0 | 2024-02-20 | Warnings | M012 |
| Nighttime Cold and Cough childrens | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Best Choice (Valu Merchandisers Company) | 11652e8a-2242-4449-8a41-a8e75509025e | 2024-02-20 | Warnings | M012 1236048 04JA59TNSJ TC2D6JAD40 |
| Nighttime sleep aid Maximum Strength | DIPHENHYDRAMINE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | 40e73317-5126-4961-8f28-60899ffbec5a | 2024-02-20 | Warnings | TC2D6JAD40 |
| Nighttime sleep aid Maximum Strength | DIPHENHYDRAMINE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | 2424fb95-06e2-49e7-aea0-7797a37aef4d | 2024-02-20 | Warnings | TC2D6JAD40 |
| Severe Sinus Relief Mist | OXYMETAZOLINE SPRAY | Walgreens Company | 847f47d9-62b1-49a3-8bb3-9bf275685bd2 | 2024-02-14 | Warnings | M012 |
| Allergy Sinus, Lil Drug Store | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE | Lil' Drug Store Products, Inc. | 1145440e-b37a-6e5e-e063-6294a90ab4a0 | 2024-02-13 | Warnings | M012 04JA59TNSJ |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | A-S Medication Solutions | 36140639-e7a8-43bc-83e2-469430af9d1a | 2024-02-13 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy, Inc | f5b609e1-e63b-2e3b-e053-2995a90a76b9 | 2024-02-12 | Warnings | TC2D6JAD40 |
| Itch stopping Cream | DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1% | Trifecta Pharmaceuticals USA, LLC. | 11368823-d4af-a536-e063-6294a90a7a2e | 2024-02-12 | Warnings | TC2D6JAD40 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | e451cb8d-f856-479f-bee9-4cccab210b1e | 2024-02-12 | Boxed warning, Warnings, Adverse reactions | 9D2RTI9KYH |
| Theraflu ExpressMax Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | ff48b55a-0d32-47d6-941d-d99c7cf52f94 | 2024-02-12 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ |
| Childrens Robitussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 15950273-14c9-4a0b-bbb4-683048add722 | 2024-02-08 | Warnings | M012 9D2RTI9KYH |
| Panadol Cold and Flu NonDrowsy | ACETAMINOPHEN AND PHENYLEPRINE HCL | Haleon US Holdings LLC | f626ab17-01c9-4493-ba9e-0c8c11146384 | 2024-02-06 | Warnings | 04JA59TNSJ |
| PANADOL PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 01e7dddb-755c-4745-b701-edcdb6209064 | 2024-02-06 | Warnings, Adverse reactions | TC2D6JAD40 |
| PANADOL PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | fe7cd1f2-9b00-4ded-99c2-8a152c71093c | 2024-02-06 | Warnings, Adverse reactions | TC2D6JAD40 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.