NDC 51316-004 - 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
- 51316-004
- Package NDCs from labels
- 51316-004-45
- 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 |
|---|---|---|---|---|---|---|
| 51316-004-45 | Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 400 mg in 20mL | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-004 | 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 |
|---|---|---|---|---|---|---|
| EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE | Kenvue Brands LLC | 19ad2cca-c1cb-019c-e063-6294a90a5644 | 2025-07-16 | Warnings | M012 |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | KROGER COMPANY | 15e54152-dc82-6442-e063-6294a90a8541 | 2025-07-16 | Warnings | 9D2RTI9KYH 495W7451VQ |
| DG HEALTH COLD FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Dolgencorp Inc | 8ea03891-2fbc-4413-8e6d-de903d426f8d | 2025-07-16 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | KROGER COMPANY | 15b98b7d-2274-450d-e063-6394a90a8d1d | 2025-07-16 | Warnings | 9D2RTI9KYH 495W7451VQ |
| MAXIMUM STRENGTH COUGH AND CONGESTION EXTENDED RELEASE | GUAIFENESIN AND DEXTROMETHORPHAN HBR | CVS Pharmacy, Inc. | 13ee8bb1-9525-a5bc-e063-6294a90a9db9 | 2025-07-16 | Warnings | 9D2RTI9KYH 495W7451VQ |
| Aller-Chord F | ACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE. | Energetix Corporation | ff4eb7b2-8272-4bd3-99a9-7e589b30d59a | 2025-07-15 | Warnings | XF417D3PSL |
| EXTRA STRENGTH PAIN RELIEF | ACETAMINOPHEN, ASPIRIN, CAFFEINE | BETTER LIVING BRANDS, LLC | eb6026d5-d88a-f6b3-e053-2a95a90a5b20 | 2025-07-15 | Warnings | 362O9ITL9D |
| Pain Relief PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Safeway | f9597abc-3f01-4b94-8078-228e0b74677e | 2025-07-15 | Warnings | 362O9ITL9D |
| up and up nighttime flu and severe cold and cough | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Target Corporation | df488727-b913-440b-9a0b-cce3ae143bf2 | 2025-07-15 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Topcare DayTime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates LLC | bb9663e3-fd11-4e72-bf85-fee4841b795f | 2025-07-15 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Berkley and Jensen Pain Relief | ACETAMINOPHEN | BJWC | d3ee3341-93b8-487c-921e-2892d213efbb | 2025-07-15 | Warnings | 362O9ITL9D |
| Good Sense Hemorrhoidal | COCOA BUTTER, PHENYLEPHRINE HCL | L. Perrigo Company | 379f8738-a871-4b09-abd1-c86386dfee04 | 2025-07-15 | Warnings | 04JA59TNSJ |
| DG HEALTH COLD FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Dolgencorp Inc | 320e4f32-66aa-48be-9afd-fa2b2c217dc1 | 2025-07-14 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Allergy Relief | DIPHENHYDRAMINE HCL | BETTER LIVING BRANDS LLC. | f29da4ca-443d-7035-e053-2a95a90acab8 | 2025-07-14 | Warnings | M012 |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Upsher-Smith Laboratories, LLC | 3aa0b733-b58f-46bd-8e76-37ddf1dc3356 | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Nikzon Hemorrhoidal | GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDE | Genomma Lab USA | 8f9a9939-2c99-489f-b597-9a51ec2684f9 | 2025-07-14 | Warnings | PDC6A3C0OX 04JA59TNSJ |
| ReVIVOL-XR | PHENYLEPHRINE HYDROCHLORIDE | Unipack LLC | 2950fe83-a2a4-4ed4-b645-69d6fd2381ae | 2025-07-13 | Warnings | 04JA59TNSJ |
| Endocrinpath | ALFALFA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, FUCUS VESICULOSUS, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, PITUITARUM POSTERIUM (BOVINE), SARSAPARILLA (SMILAX REGELII), SILICEA, SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE) | Energetix Corporation | 70f84941-b8a1-48f4-9c05-554e554f0049 | 2025-07-11 | Warnings | XF417D3PSL |
| EXTRA PAIN RELIEF | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | TIME CAP LABS | 59482917-f80b-4bed-9218-068b35366eb3 | 2025-07-11 | Warnings | 362O9ITL9D |
| CVS PHARMACY MS Adult Severe Multi Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS PHARMACY | cdc9af7c-3766-4573-9d95-bf217907b932 | 2025-07-11 | Warnings | M012 9D2RTI9KYH 362O9ITL9D 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.