Home NDC 49580-0502-08 NDC 49580-0502-08 - Nighttime Severe Cold and Cough 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 49580-0502
Requested NDC 49580-0502-08
Package NDCs from labels 49580-0502-8, 49580-0502-08
Manufacturer P & L Development, LLC
Effective date 2024-04-15
Current FDA listing Not matched in FDA.report NDC product tables FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49580-0502-8 Nighttime Severe Cold and Cough 245 mL in 1 BOTTLE, PLASTIC LIQUID 245 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0502 NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [P & L DEVELOPMENT, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20240417_8d27b94d-23a1-4e6c-a064-79e2580f7e2e.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.
Matched openFDA labels page 8 of 478 · 9,557 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dextromethorphan HBr DEXTROMETHORPHAN HBR BIONPHARMA INC. 5a5dde85-8785-8149-e063-6294a90a4d57 2026-08-31 Warnings Exact identifier application number: M012 Equate Nasal OXYMETAZOLINE HCL Sixarp, LLC 5a5e2458-bab0-4931-e063-6394a90ad606 2026-08-31 Warnings Exact identifier application number: M012 MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF DEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOL Reckitt Benckiser LLC 8d670d91-9e22-45b9-b568-5b62c2133d32 2026-08-31 Warnings Exact identifier application number: M012 Daytime Cold and Flu Multi Symptom Relief ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL Shield Pharmaceuticals Corp e85b4c2a-d4e0-452c-9a08-fcc0ff6eaa21 2026-08-31 Warnings Exact identifier application number: M012 unii: 04JA59TNSJ unii: 362O9ITL9D MAX relief junior Grape CHILDRENS ACETAMINOPHEN Akron Pharma Inc. cc769c26-556a-4831-bd75-61a7383aa707 2026-08-31 Warnings Exact identifier unii: 362O9ITL9D MAX relief junior CHILDRENS ACETAMINOPHEN Akron Pharma Inc. ebb3b4ba-2d0b-48d9-b6ee-6d4696aea047 2026-08-31 Warnings Exact identifier unii: 362O9ITL9D Daytime Cold and Flu Maximum Strength ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL Shield Pharmaceuticals Corp 67849e09-2056-4013-98b1-d003ed3250a2 2026-08-31 Warnings Exact identifier application number: M012 unii: 04JA59TNSJ unii: 362O9ITL9D MAX relief junior ACETAMINOPHEN Akron Pharma Inc. 0e43b885-3843-4f11-9a53-02a38c228313 2026-08-31 Warnings Exact identifier unii: 362O9ITL9D MAX relief junior CHILDREN ACETAMINOPHEN Akron Pharma Inc. d7874e4d-0b38-4bb1-9a62-aa4f66d9baf9 2026-08-31 Warnings Exact identifier unii: 362O9ITL9D MAX relief junior Grape CHILDREN ACETAMINOPHEN Akron Pharma Inc. 3c7a7f40-4963-4fd1-942e-93fa08a45830 2026-08-31 Warnings Exact identifier unii: 362O9ITL9D Genexa Kids Pain and Fever ACETAMINOPHEN Genexa Inc. 5a615118-33c9-1520-e063-6394a90a21a6 2026-08-31 Warnings Exact identifier unii: 362O9ITL9D MAX Tussin Mucus and Chest Congestion Sugar Free GUAIFENESIN Akron Pharma Inc. 3b023b91-e703-4599-9864-96d8c328b45c 2026-08-31 Warnings Exact identifier application number: M012 MAX Tussin Mucus and Chest Congestion GUAIFENESIN Akron Pharma Inc. ac874a31-5556-4669-937f-dcb52aaecd8a 2026-08-31 Warnings Exact identifier application number: M012 hydrating mist hand sanitizer with silicone keychain holder - beaver nuggets ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. f875e065-7b3e-45dc-8a33-b893ab830695 2026-08-31 Warnings Exact identifier unii: 3K9958V90M hydrating mist hand sanitizer with silicone keychain holder - signature scent ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. 30e11bf0-1a21-45b1-adf9-cf3845419a98 2026-08-31 Warnings Exact identifier unii: 3K9958V90M MAX Tussin Cough and Chest Congestion DM DEXTROMETHORPHAN HBR, GUAIFENESIN Akron Pharma Inc. e0ce4287-bfa1-4413-97c8-4fe2e39bda36 2026-08-31 Warnings Exact identifier application number: M012 Itch Stopping DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE HyVee Inc 53157137-b980-45d2-aa10-8c111c0ec2f4 2026-08-31 Warnings Exact identifier unii: TC2D6JAD40 Swisher Instant Hand Sanitizer Gel ALCOHOL Ecolab Inc. 1f84e842-ece4-4eb7-9ccf-d86cec78dbf2 2026-08-31 Warnings Exact identifier unii: 3K9958V90M Acetaminophen PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL United Natural Foods, Inc. dba UNFI 24173e77-92ec-4a87-a471-d6867837c180 2026-08-31 Warnings Exact identifier application number: M012 unii: TC2D6JAD40 unii: 362O9ITL9D Smart Care Hand Sanitizer(Oval Shape)with Beaded Wristlet - Cherry Blossom ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 5a4fb4b6-ba9e-5b82-e063-6294a90a4734 2026-08-30 Warnings Exact identifier unii: 3K9958V90M
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.