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 75 of 316 · 6,314 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED1fcbafaa-c871-db6d-e063-6394a90aab5e2026-01-28WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED1f7a6375-ab66-9782-e063-6394a90a99f32026-01-28WarningsExact identifier
unii: 362O9ITL9D
ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCIMEDWISE LIFESCIENCES INC.4970b8bc-3c7b-4b8a-e063-6294a90a7f1b2026-01-28WarningsExact identifier
unii: 362O9ITL9D
SHISEIDO SPORTS BB DARKOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONf4fc4b6a-9507-496e-9ecb-8400055ecf2d2026-01-28WarningsExact identifier
unii: 15FIX9V2JP
Hampton Sun SPF 30 MineralZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCb8ee428e-07d3-4c6c-853c-cfbe3e4002d92026-01-28WarningsExact identifier
unii: 15FIX9V2JP
Alka-Seltzer Pain ReliefALKA-SELTZER PAIN RELIEFBayer HealthCare LLC.4975f0ff-0480-7fca-e063-6294a90aef2f2026-01-28WarningsExact identifier
application number: M013
Extra Strength Mini Softgels Pain RelieverACETAMINOPHENTHE KROGER COb49aae4f-b040-44a0-be73-cdf45cf14d7e2026-01-28WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Walgreens Original Strength Anti ItchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEWalgreen Companya6a49dbb-74c7-47ca-88f2-3bb3d9acf9142026-01-28WarningsExact identifier
unii: TC2D6JAD40
Extra Strength AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.b25faa8c-2d13-450a-970f-81c17a6330302026-01-28WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Daytime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBRFamily Dollar (FAMILY WELLNESS)fe3e74ba-31d9-4d50-ab61-ffb6aaa660852026-01-28WarningsExact identifier
unii: 362O9ITL9D
Leader Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. dba Leader9b1a5dbe-39dd-4dbb-800c-0cef422ae7c52026-01-28WarningsExact identifier
unii: 362O9ITL9D
Sleep Aid Night TimeDIPHENHYDRAMINE HCLDOLGENCORP, LLCd805fab3-9dca-497f-bdc6-c8a7b17361092026-01-27WarningsExact identifier
unii: TC2D6JAD40
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company93d5b1db-e9ad-4a6a-b869-fd0d1a11df022026-01-27WarningsExact identifier
unii: 362O9ITL9D
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc53a3e6a7-d625-4393-95eb-bb6f86e86cc12026-01-27WarningsExact identifier
unii: TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED32074a31-326b-4aaf-e063-6394a90a0d402026-01-27WarningsExact identifier
unii: TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED335b6ddd-fdc8-1120-e063-6394a90add412026-01-27WarningsExact identifier
unii: TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0e45d0e8-3741-7cee-e063-6394a90a2de52026-01-27WarningsExact identifier
unii: TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd335b09c6-ee5d-ebdf-e063-6294a90abd122026-01-27WarningsExact identifier
unii: TC2D6JAD40
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED37e8ccd5-6be1-9aca-e063-6394a90a52632026-01-27WarningsExact identifier
unii: 362O9ITL9D
Diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd32033991-a4f0-f767-e063-6394a90a0b062026-01-27WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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