FDA.reportPublic FDA data

NDC 11868-390-58 - Tronolane

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
11868-390
Requested NDC
11868-390-58
Package NDCs from labels
11868-390-28, 11868-390-48, 11868-390-58, 11868-390-59
Manufacturer
New Genesis/Monticello Drug LLC | ULTRAtab Laboratories, Inc.
Effective date
2018-01-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tronolane ®New Genesis/Monticello Drug LLC | ULTRAtab Laboratories, Inc.2018-01-30HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
11868-390-482023-01-05Tronolane ®
11868-390-592023-01-05Tronolane ®
11868-390-482021-01-29Tronolane ®
11868-390-592021-01-29Tronolane ®

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5TRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]5
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZTRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]5
PRAMOXINEACTIVE MOIETY068X84E056TRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]5
ZINC CATIONACTIVE MOIETY13S1S8SF37TRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]5
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]5
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUTRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RTRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]5
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VTRONOLANE (PRAMOXINE HCL) CREAM [NEW GENESIS/MONTICELLO DRUG LLC]5

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 237 · 4,738 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
unii: SOI2LOH54Z
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: SOI2LOH54Z
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
unii: 88AYB867L5
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Jack Black Sun Guard Sunscreen SPF45SUNSCREENJack Black, LLC3cc86bb2-05ce-47eb-8c71-f4f116ca58402026-09-08WarningsExact identifier
unii: SOI2LOH54Z
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
unii: 88AYB867L5
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 88AYB867L5
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
unii: 88AYB867L5
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLWalgreen Companyb982091a-5aa0-4bbc-bb1d-08016f6d0a702026-09-03WarningsExact identifier
unii: 88AYB867L5
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-09-01WarningsExact identifier
unii: SOI2LOH54Z
Maximum Strength Betadine ClearBENZALKONIUM CL AND PRAMOXINE HCLAtlantis Consumer Healthcare, Inc.31b94a76-1536-47c0-ab03-e487c2625c582026-08-31WarningsExact identifier
unii: 88AYB867L5
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsExact identifier
unii: SOI2LOH54Z
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.5a3a59b2-18b6-521b-e063-6294a90a29582026-08-29WarningsExact identifier
unii: SOI2LOH54Z
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsExact identifier
unii: SOI2LOH54Z
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsExact identifier
unii: SOI2LOH54Z
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsExact identifier
unii: SOI2LOH54Z
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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