FDA.reportPublic FDA data

NDC 70000-0191-02 - Leader Daytime 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
70000-0191
Requested NDC
70000-0191-02
Package NDCs from labels
70000-0191-1, 70000-0191-2, 70000-0191-02
Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2026-04-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leader Daytime Cold and Flu - Cardinal Health 110, LLC. dba LeaderCardinal Health 110, LLC. dba Leader2026-04-25HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0191-1Leader Daytime Cold and Flu237 mL in 1 BOTTLESOLUTION2376
70000-0191-2Leader Daytime Cold and Flu355 mL in 1 BOTTLESOLUTION3556

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0191LEADER DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER]6Current NDC, Legacy NDC, 2 package rows20240927_333c7042-95b8-4d98-9df1-4287017afa36.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0191-1ML - Milliliter70000-0191ad7de9ea-e4fb-406d-8c0d-079e5ee1905712019-01-24
70000-0191-2ML - Milliliter70000-0191c0d6e22a-9c8f-4466-964c-d8d862c4b81912019-01-24

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 1 of 570 · 11,397 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll OnMENTHOLChattem, Inc.aa40c907-eeb5-4fda-b35e-439cbecc178c2026-07-31WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-07-30WarningsExact identifier
unii: 362O9ITL9D
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDELifestar Pharma LLC1767c4b7-36a0-4e64-9091-2af22161402f2026-07-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Aspercreme with Lidocaine DryLIDOCAINEChattem, Inc.008abaaa-5e12-4246-a7f5-66f3966acf282026-07-30WarningsExact identifier
application number: M017
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
unii: 362O9ITL9D
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
Icy Hot Performance No-Mess Pain Relief CreamMENTHOL 16%, CAMPHOR 11%Chattem, Inc.5e3e272a-c001-4f57-9535-521ccc85ae652026-07-30WarningsExact identifier
application number: M017
unii: L7T10EIP3A
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDELifestar Pharma LLCf43e4abd-0083-4fe5-9c27-0ba9245e51382026-07-30Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Auixudin Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.57bc7b9e-e2f7-724b-e063-6394a90ab36f2026-07-29WarningsExact identifier
application number: M017
Jinfahe Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.57bcd9c5-767e-b634-e063-6394a90a28782026-07-29WarningsExact identifier
application number: M017
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEREMEDYREPACK INC.4c966d73-77c6-4514-954e-57aa06a080c62026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Maximun Strength Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLMeijer Distribution Incd0468514-58ea-4d8f-b634-a65bf95c03162026-07-29WarningsExact identifier
application number: M017
unii: L7T10EIP3A
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
KinderFarms Infants Pain and FeverACETAMINOPHENKinderFarms, LLC5468b149-8fac-8d6a-e063-6294a90a8c512026-07-29WarningsExact identifier
unii: 362O9ITL9D
Oudetas Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.57ca9220-2778-790a-e063-6294a90af5062026-07-29WarningsExact identifier
application number: M017