NDC 51316-063 - Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, Nighttime
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
- 51316-063
- Package NDCs from labels
- 51316-063-45
- Manufacturer
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.
- Effective date
- 2025-10-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| CVS 44-004063 | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc. | 2025-10-17 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-063-45 | Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 650 mg in 20mL | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-063 | SEVERE CONGESTION, COUGH, COLD AND FLU RELIEF MAXIMUM STRENGTH, NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) KIT [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] | 4 | Unmatched | 20241017_92c570ff-139f-49ff-a7bd-8a540ecc07c7.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 |
|---|---|---|---|---|---|---|
| Guaifenesin DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | PD-Rx Pharmaceuticals, Inc. | ac8c0c15-b305-47f2-8712-e4b53636f7fa | 2023-10-02 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| childrens mapap | ACETAMINOPHEN | Proficient Rx LP | 88c4183a-3032-46de-bf18-f700055f617b | 2023-10-01 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen, Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Proficient Rx LP | d860af16-fab4-4263-9e66-a648d5e81dab | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Zensa Numbing Gel | LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25% | Alera Skin Care Products Inc. | 065a6eec-3896-0da8-e063-6394a90a849d | 2023-09-27 | Warnings | 04JA59TNSJ |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | XLCare Pharmaceuticals, Inc. | b9f61b9c-d3f9-47e3-94a3-b5228f96f927 | 2023-09-25 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Maximum strength Day cold and flu and Night severe cold and flu | ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS | TIME CAP LABORATORIES,INC | fff69901-965c-5372-e053-6394a90a29c2 | 2023-09-18 | Warnings | M012 |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | Eugia US LLC | 303bc1e6-0735-4ea1-84cd-6c1b621de0ed | 2023-09-16 | Warnings, Adverse reactions | 04JA59TNSJ |
| Mucus Relief | GUAIFENESIN | United Natural Foods, Inc. dba UNFI | e7d457a6-05f9-407c-bf9b-a82e3cf2568c | 2023-09-07 | Warnings | 495W7451VQ |
| ANUBISMED | HA HYALURONIC | ANUBIS COSMETICS SL | eac771e2-4c1b-3808-e053-2995a90ac5fc | 2023-09-05 | Warnings | 6DC9Q167V3 PDC6A3C0OX 059QF0KO0R |
| AnubisMed | SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION | ANUBIS COSMETICS SL | e99d92c4-8768-9c0a-e053-2a95a90a609e | 2023-09-05 | Warnings | 6DC9Q167V3 PDC6A3C0OX 059QF0KO0R XF417D3PSL |
| AnubisMed | AZELAIC ACID, SALICYLIC ACID | ANUBIS COSMETICS SL | ebf3153d-30f5-54e4-e053-2995a90a74b1 | 2023-09-05 | Warnings | 6DC9Q167V3 059QF0KO0R |
| AnubisMed | GLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACID | ANUBIS COSMETICS SL | eca95dde-cb57-2ab6-e053-2995a90af84f | 2023-09-05 | Warnings | 6DC9Q167V3 059QF0KO0R |
| AnubisMed | SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA | ANUBIS COSMETICS SL | ebf4b3ab-34e1-185a-e053-2a95a90ace3a | 2023-09-05 | Warnings | 059QF0KO0R |
| Lipotox | SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, | BioActive Nutritional, Inc. | a1538692-ca00-4e52-9b7e-409767ee27e1 | 2023-09-05 | Warnings | OJ245FE5EU 506T60A25R |
| Anubis Barcelona | GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE | ANUBIS COSMETICS SL | eb651769-4d98-2b3b-e053-2a95a90a36b0 | 2023-09-01 | Warnings | PDC6A3C0OX 059QF0KO0R H3R47K3TBD 506T60A25R |
| Anubis Barcelona | DMAE | ANUBIS COSMETICS SL | f22b212d-d21d-5984-e053-2995a90a683e | 2023-09-01 | Warnings | PDC6A3C0OX 059QF0KO0R TTV12P4NEE |
| Anubis Barcelona | DMAE, ZIRHAFIRM | ANUBIS COSMETICS SL | f2274f8c-08aa-eb02-e053-2a95a90a3998 | 2023-09-01 | Warnings | PDC6A3C0OX 059QF0KO0R TTV12P4NEE |
| Anubis Barcelona | PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOIN | ANUBIS COSMETICS SL | eb9244ea-6102-3cbe-e053-2a95a90ab8f6 | 2023-09-01 | Warnings | 6DC9Q167V3 059QF0KO0R |
| Anubis Barcelona | PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL | ANUBIS COSMETICS SL | ebdddcec-f5da-51fe-e053-2995a90a6167 | 2023-09-01 | Warnings | PDC6A3C0OX 059QF0KO0R TTV12P4NEE |
| Anubis Barcelona Regul Oil | PROPYLENE GLYCOL, PANTHENOL, THIAMINE HCL | ANUBIS COSMETICS SL | eb8e5beb-4452-58c2-e053-2a95a90a66e0 | 2023-09-01 | Warnings | 6DC9Q167V3 PDC6A3C0OX 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.