FDA.reportPublic FDA data

NDC 0363-6219 - WAG HBP Daytime and Nighttime Cold and Flu

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
0363-6219
Package NDCs from labels
0363-6219-16
Manufacturer
WALGREENS CO.
Effective date
2025-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Walgreen HBP Nighttime and Daytime Cold & Flu Value PackWALGREENS CO.2025-12-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-6219-16WAG HBP Daytime and NighttimeCold and Flu236 mL in 1 BOTTLE, PLASTICLIQUID236 mL650 mg in 30mL4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6219WAG HBP DAYTIME AND NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) KIT [WALGREENS CO.]3Unmatched20241114_ac2f9ce8-e402-4451-a412-e99248a6ecbe.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 4 of 367 · 7,325 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEShield Pharmaceuticals Corpdecafa3a-3734-4161-bab0-1219458818462026-09-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
unii: 362O9ITL9D
Kroger Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCLKROGER COMPANY1ff037ea-1a3b-430a-be31-2e240cc3b6f32026-09-02WarningsExact identifier
unii: 9D2RTI9KYH
SLEEP AIDDOXYLAMINE SUCCINATEAmazon.com Services LLCc4509e0a-cb9d-454c-a67b-812a0ba62be12026-09-02WarningsExact identifier
unii: V9BI9B5YI2
KROGER Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINKROGER COMPANY79d24014-1af7-4d62-bcb8-5bea76a7d6ee2026-09-02WarningsExact identifier
unii: 9D2RTI9KYH
Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANYe1d27123-358f-4b0c-8e3b-33474750a0e62026-09-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Kroger Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKroger Companyc5ce0901-a5d7-46c4-8492-5a80c76e85172026-09-02WarningsExact identifier
rxcui: 1043400
unii: 9D2RTI9KYH
unii: V9BI9B5YI2
unii: 362O9ITL9D
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLThe Kroger Co.494e69ef-dc9f-4e14-b856-5eaf0f541a032026-09-02WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Leader Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leader7c54d128-9da7-49d7-bda4-9d4f7b8bc6522026-09-01WarningsExact identifier
unii: 9D2RTI9KYH
MAX Tussin Cough and Chest Congestion DM Sugar FreeDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.5c4c8115-cec9-4f2c-9ea9-328535e97b072026-09-01WarningsExact identifier
unii: 9D2RTI9KYH
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
unii: L7T10EIP3A
Ramedica Herbal Wonder BalmCAMPHOR, MENTHOLRamedicare Sdn. Bhd.cfb2ea0e-a1f6-4fdf-b866-346bbe78788f2026-09-01WarningsExact identifier
unii: L7T10EIP3A
Adult Low Dose Chewable AspirinASPIRINFarmacias De Similares TX LLC513ea306-74c6-96e3-e063-6394a90a82622026-09-01WarningsExact identifier
application number: M013
La Vaquita New RegularMETHYL SALICYLATEDelon Laboratories (1990) Ltdd62186ac-afbb-443e-98c2-f0d122422a3c2026-09-01WarningsExact identifier
unii: L7T10EIP3A
ActivICEMENTHOLMedline Industries, LP834adeb9-38ad-0cfe-e053-2991aa0af82f2026-09-01WarningsExact identifier
unii: L7T10EIP3A
La Vaquita New ExtraMETHYL SALICYLATE, MENTHOLDelon Laboratories (1990) Ltd3097a01b-cee5-492f-b65a-63992fb28e3a2026-09-01WarningsExact identifier
unii: L7T10EIP3A
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREEHEXYLRESORCINOL AND MENTHOLReckitt Benckiser LLC4a938e15-a996-8538-e063-6294a90ad4ee2026-09-01WarningsExact identifier
unii: L7T10EIP3A
Kroger Children Pain plus Fever chewablesACETAMINOPHENKROGER COMPANY83b5733c-70a1-4383-9729-2eb896d0149a2026-09-01WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)923b443d-73cc-4c52-92e4-a075786b1ae32026-09-01WarningsExact identifier
application number: M013
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.