FDA.reportPublic FDA data

NDC 75587-151 - PBZ OTC

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
75587-151
Package NDCs from labels
75587-151-02
Manufacturer
Kingsway Pharmaceuticals dba NFI, LLC
Effective date
2025-08-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PBZ OTC - Kingsway Pharmaceuticals dba NFI, LLCKingsway Pharmaceuticals dba NFI, LLC2025-08-29HUMAN OTC DRUG LABEL
PBZ OTC - IBR Packaging, LLCIBR Packaging, LLC2025-04-10HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75587-151PBZ OTC (TRIPELENNAMINE HCL 1%) CREAM [IBR PACKAGING, LLC]1Unmatched20250412_a709a20b-c816-41be-afb9-b487e339dc43.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 138 of 220 · 4,392 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Infants Non staining Gas reliefSIMETHICONERetail Business Services, LLC.1501bee6-4734-4836-8573-54af919d42212025-02-27WarningsExact identifier
unii: 92RU3N3Y1O
Lidocaine Pain-Relief PatchesLIDOCAINE PATCHMeijer, Inc2f247929-6bff-1e59-e063-6394a90acdba2025-02-27WarningsExact identifier
application number: M017
Lightning Products BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.555ac696-e761-4a5a-bed8-945dc64d5be52025-02-27WarningsExact identifier
application number: M017
Anti-Diarrheal/Anti-GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEDiscount Drug Mart, Inc2e0b3aec-f436-c0fb-e063-6394a90abb512025-02-27WarningsExact identifier
unii: 92RU3N3Y1O
Hydrocortisone with aloeHYDROCORTISONEEncube Ethicals, Inc.12a1774d-a97e-4787-b6b1-8e8cd40b7b702025-02-26WarningsExact identifier
application number: M017
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLCf553374b-c20e-4c92-a8c0-cef0aeda8d1c2025-02-26WarningsExact identifier
unii: 92RU3N3Y1O
Thera Plus Maximum Strength Feminine Anti-ItchBENZOCAINE, RESORCINOLFOURSTAR GROUP USA, INC.0007e3ea-882b-4000-8e70-2bcec2c086132025-02-26WarningsExact identifier
application number: M017
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Tattoo numbing creamLIDOCAINEBLOOMWELL GARDENS LLC2ea9d34e-408d-f8d6-e063-6394a90a72a42025-02-26WarningsExact identifier
application number: M017
Icy Hot Pro No-MessCAMPHOR, MENTHOLChattem, Inc.9e8fedf5-fb59-4531-b288-715f851ee05b2025-02-26WarningsExact identifier
application number: M017
Family Wellness Max Strength 1 Hydrocortisone CreamHYDROCORTISONEFamily Dollar Stores, Incbca5ac2c-45cd-44e3-98f1-317a04e44d7d2025-02-25WarningsExact identifier
application number: M017
Tylenol Precise Nighttime Pain RelievingCAMPHOR, MENTHOLKenvue Brands LLC2ef4fe16-0820-6aad-e063-6294a90a84492025-02-25WarningsExact identifier
application number: M017
Blink Nourish Dry EyeGLYCERINBausch & Lomb Incorporatedcf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a42025-02-25WarningsExact identifier
unii: PDC6A3C0OX
SIMETHICONESIMETHICONENuCare Pharmaceuticals,Inc.e07f6acc-1b75-d8eb-e053-2a95a90a7d9b2025-02-24WarningsExact identifier
unii: 92RU3N3Y1O
Extra Strength Gas Relief Cherry FlavorSIMETHICONEDiscount Drug Mart, Inc2df821f6-e4b5-89ae-e063-6394a90ad4162025-02-24WarningsExact identifier
unii: 92RU3N3Y1O
Se-Natal 19.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE AND DOCUSATE SODIUMSeton Pharmaceuticals635104e6-6a53-4684-ac9a-7ac31b33083d2025-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WR1WPI7EW8
Mineral oilMINERAL OILP & L Development, LLC68e88119-1468-4ab7-a5fa-242d960d25df2025-02-21WarningsExact identifier
unii: T5L8T28FGP
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEPreferred Pharmaceuticals Inc.c259ef92-5d07-4590-adf1-3a106333eee02025-02-21WarningsExact identifier
application number: M017
Cortizone 10 Ultra Soothing Itch ReliefHYDROCORTISONEChattem, Inc.8a9e2d32-a65f-4253-8041-4146f4e3b7382025-02-21WarningsExact identifier
application number: M017
Gas reliefSIMETHICONEDiscount Drug Mart, Inc2df9117a-97cc-532d-e063-6294a90a1a9c2025-02-20WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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