FDA.reportPublic FDA data

NDC 53209-1002-01 - Tylenol PM 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
53209-1002
Requested NDC
53209-1002-01
Package NDCs from labels
53209-1002-1, 53209-1002-2, 53209-1002-01
Manufacturer
Morning Star OTC
Effective date
2025-06-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tylenol PM Extra Strength - Morning Star OTCMorning Star OTC2025-06-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53209-1002-1Tylenol PMExtra Strength2 in 1 BLISTER PACKTABLET, FILM COATED21
53209-1002-2Tylenol PMExtra Strength25 in 1 POUCHTABLET, FILM COATED251

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 59 of 317 · 6,328 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Pain and FeverACETAMINOPHENPreferred Pharmaceuticals Inc.7dbd0a2d-8597-4010-bfe2-94a8d145ca572026-03-27WarningsExact identifier
unii: 362O9ITL9D
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADETITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC4e0bd355-99c6-8cf4-e063-6294a90ab4b32026-03-27WarningsExact identifier
unii: 15FIX9V2JP
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCHAIN DRUG MARKETING ASSOCIATION INC7d1b3418-85a8-4ca0-bca7-261b2b58032a2026-03-26WarningsExact identifier
unii: 362O9ITL9D
Childrens AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.68e214cd-2d09-42d0-a4e9-b1b81af6be3c2026-03-26WarningsExact identifier
unii: 362O9ITL9D
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEA-S Medication Solutionseedb421c-0020-4e5f-8b09-26a1cbabb6812026-03-26Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
Good Sense Childrens Pain and FeverACETAMINOPHENPreferred Pharmaceuticals Inc.a00dc563-6611-46b8-ab5c-1b2c602f3c682026-03-26WarningsExact identifier
unii: 362O9ITL9D
MAXIMUM STRENGTH COLD, FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Inc.bfc38500-5706-0d03-e053-2995a90a5c722026-03-26WarningsExact identifier
unii: 362O9ITL9D
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS HEALTH CORP2baa0861-dbef-7910-e063-6394a90a117e2026-03-26WarningsExact identifier
unii: 362O9ITL9D
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
AspirinASPIRINPD-Rx Pharmaceuticals, Inc.d1f05e56-c830-4f85-b685-2a5965d10a1c2026-03-26WarningsExact identifier
application number: M013
SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On MineralZINC OXIDE, TITANIUM DIOXIDEClassic Cosmetics LLC4df3b8c0-71bc-acdd-e063-6394a90a35c02026-03-26WarningsExact identifier
unii: 15FIX9V2JP
Vicks childrens Cough Congestion NightPHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company87231460-8b45-b995-e053-2a91aa0a6c432026-03-26WarningsExact identifier
unii: TC2D6JAD40
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackf1a7d87c-866d-4c6d-b9fd-e809b0a217732026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
M-PAPACETAMINOPHENBryant Ranch Prepackad01aea6-4af3-469b-b99d-e1e66aa40e8d2026-03-25WarningsExact identifier
application number: M013
unii: 362O9ITL9D
flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRMeijer Distribution Inc1a853e47-21a2-40e1-9e64-290af4843b132026-03-25WarningsExact identifier
unii: 362O9ITL9D
cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHyVee Incc4dcc427-aeec-4a26-80f3-02a4b227a5202026-03-25WarningsExact identifier
unii: 362O9ITL9D
aspirinASPIRINMeijer Distribution Incc550b92e-de54-4599-9534-bd3022b0a86d2026-03-25WarningsExact identifier
application number: M013
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETWIN MED LLC7b000478-649d-4511-b3e0-eea6995b97842026-03-25WarningsExact identifier
unii: TC2D6JAD40
Silkscreen Sheer Tint Mineral Light-MediumTITANIUM DIOXIDE, ZINC OXIDECurology4ddbe349-6880-a5fc-e063-6294a90a275c2026-03-25WarningsExact identifier
unii: 15FIX9V2JP
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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