FDA.reportPublic FDA data

NDC 85237-1946-01 - TYLENOL Extra Strength

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
85237-1946
Requested NDC
85237-1946-01
Package NDCs from labels
85237-1946-0, 85237-1946-1, 85237-1946-2, 85237-1946-3, 85237-1946-4, 85237-1946-5, 85237-1946-6, 85237-1946-7, 85237-1946-01
Manufacturer
Select Consumer Group LLC
Effective date
2026-06-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TYLENOL Extra Strength - Select Consumer Group LLCSelect Consumer Group LLC2026-06-27HUMAN OTC DRUG LABEL

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 54 of 286 · 5,707 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLBetter Living Brands, LLCb7b1c3cc-fdf3-4e75-8c3f-2e832f09a8872026-03-24WarningsExact identifier
unii: 362O9ITL9D
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCed28bfa9-3768-4f42-ae5e-1c527b4456d12026-03-24WarningsExact identifier
unii: 362O9ITL9D
Sinus Severe DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCb65baa7c-8197-4361-b3ef-e60eba38dca12026-03-24WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain RelieverACETAMINOPHENBJWC (Berkley & Jensen / BJ's)851228ea-eaf3-452b-a9ce-8cd244a0eaf32026-03-24WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Mucus Relief Congestion and Headache Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2638b541-e680-4949-a7c7-fcee165cbc922026-03-23WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackdb14e63a-8e3e-4524-b45a-cb09f705f73a2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacke5b559c3-4beb-4ba3-a10b-7a1ad1878a1e2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack1170f2f0-f087-4b68-afb5-7c049cb9a6192026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREENZINC OXIDEENS KOREA Co., Ltd.34f9688d-efa1-1d3f-e063-6294a90ab1272026-03-23WarningsExact identifier
unii: 15FIX9V2JP
HALORINNA SUN-SCREEN TRAVEL SPF50SUN SCREENGuangdong Bisutang Biotechnology Co., LTD4dade579-ce77-eea5-e063-6394a90ad46a2026-03-23WarningsExact identifier
unii: 15FIX9V2JP
Daytime Severe Cold and FluACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGrocery Outlet, Inc.4db0470b-1bf0-9137-e063-6394a90a1d542026-03-23WarningsExact identifier
unii: 362O9ITL9D
Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGrocery Outlet, Inc.4db066d4-ddbe-ddce-e063-6394a90ac5f82026-03-23WarningsExact identifier
unii: 362O9ITL9D
FirstCare Childrens Pain Fever AcetaminophenACETAMINOPHEN 80 MGUSpharma Ltd9fc05ba6-5667-457e-82c1-a8b4e16cadda2026-03-23WarningsExact identifier
application number: M013
unii: 362O9ITL9D
AspirinASPIRINAarkish Pharmaceuticals NJ Inc.e5e9e1ce-666a-461f-8287-a4642902067c2026-03-23WarningsExact identifier
application number: M013
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepacke73b17c4-9f24-4b32-8920-61c58c40a7142026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackc534f784-0e21-4891-8f7e-2dc327b267f12026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack879db1b5-6365-4151-9879-80d8a2a3cd8a2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4e2a8b53-0074-42fd-8357-a39cc6afe6082026-03-23WarningsExact identifier
unii: 362O9ITL9D
hydrocodone bitartrate and acetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackafdc6256-f7d0-404b-a377-328250ab29ff2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Mucus Relief Severe Cold Daytime Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET Corporation5ccaf3b0-096a-4644-9c6e-9f251c167b3c2026-03-23WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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