NU-DERM SYSTEM NORMAL-OILY

Product NDC
62032-513
11-digit product format
620320513
Labeler code
62032
Product ID
62032-513_76204b7d-f856-4aa7-91d3-a04432eb9254
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroquinone, Octinoxate, and Zinc Oxide
Dosage form
KIT
Labeler
OMP, INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2012-11-07
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62032-513IInactivated by FDA2026-10-05
excluded packagepackage62032-51362032-513-00IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62032-513-00IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62032-513-00IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62032-513-00IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62032-513-00IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62032-513-00IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62032-513-00IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62032-513-00IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62032-513-00IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62032-513-00IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62032-513-00IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62032-513-00IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62032-513-00IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage62032-513-00IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage62032-513-00IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage62032-513-00IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage62032-513-00IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage62032-513-00IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage62032-513-00IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage62032-513-00IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage62032-513-00IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage62032-513-00IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage62032-513-00EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-513-002020-01-31C16284748780-19d75b9d0-3c2b-f424-e053-dadaa90a57ceNU-DERM ® SYSTEM NORMAL-OILY SKIN TRANSFORMATION KIT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-100-36NU-DERM SYSTEM NORMAL-OILYSKIN TRANSFORMATION57 g in 1 BOTTLE, PLASTICCREAM57 g40 mg in 1g1
62032-101-36NU-DERM SYSTEM NORMAL-OILYSKIN TRANSFORMATION57 g in 1 BOTTLE, PLASTICCREAM57 g40 mg in 1g1
62032-104-90NU-DERM SYSTEM NORMAL-OILYSKIN TRANSFORMATION85 g in 1 TUBELOTION85 g75 mg in 1g1
62032-513-00NU-DERM SYSTEM NORMAL-OILYSKIN TRANSFORMATION1 in 1 CARTONKIT11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROQUINONEACTIVE INGREDIENTXV74C1N1AENU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
HYDROQUINONEACTIVE MOIETYXV74C1N1AENU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1GNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
HYDROGENATED PALM GLYCERIDESINACTIVE INGREDIENTYCZ8EM144QNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ4NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFANU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM0NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q7NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
PPG-2 MYRISTYL ETHER PROPIONATEINACTIVE INGREDIENT88R97D8U8ANU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
SODIUM DIHYDROXYCETYL PHOSPHATEINACTIVE INGREDIENTYWI33EV595NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
SQUALANEINACTIVE INGREDIENTGW89575KF9NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
TROLAMINE SALICYLATEINACTIVE INGREDIENTH8O4040BHDNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
TROPOLONEINACTIVE INGREDIENT7L6DL16P1TNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
UBIDECARENONEINACTIVE INGREDIENTEJ27X76M46NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-513NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION ( HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE) KIT [OMP, INC.]1Legacy NDC, 4 package rows20130112_945ddb26-75b4-4f7c-94f2-7d8047cd3c51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197795hydroquinone 4 % Topical CreamPSN945ddb26-75b4-4f7c-94f2-7d8047cd3c511
197795hydroquinone 40 MG/ML Topical CreamSCD945ddb26-75b4-4f7c-94f2-7d8047cd3c511
197795hydroquinone 4 % Topical CreamSY945ddb26-75b4-4f7c-94f2-7d8047cd3c511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
62032-100-366203201003657 g in 1 BOTTLE, PLASTIC57 gHistorical
62032-101-366203201013657 g in 1 BOTTLE, PLASTIC57 gHistorical
62032-104-906203201049085 g in 1 TUBE85 gHistorical
62032-513-00620320513001 in 1 CARTONHistorical