FDA.reportPublic FDA data

Nighttime Control

Product NDC
76458-333
11-digit product format
764580333
Labeler code
76458
Product ID
76458-333_0c86a86e-1d0e-8fa8-e063-6294a90a5963
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Circadia by Dr Pugliese, Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-07-15
Substance
BENZOYL PEROXIDE
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct76458-333IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage76458-33376458-333-02IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Nighttime Control
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W9WZN9A0GMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
106309Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb4cc832-4cfd-4e29-a78e-ab848681a224Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76458-333-022020-02-29C16284748780-197449f38-c81e-f6ea-e053-dbdaa90aa703Nighttime Control
76458-333-022019-11-13C16284748780-197449f38-c81e-f6ea-e053-dbdaa90aa703Nighttime Control

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76458-333-02Nighttime Control1 in 1 CARTONLOTION15
76458-333-02Nighttime Control59 mL in 1 BOTTLELOTION595

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMNIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMNIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
ALLANTOININACTIVE INGREDIENT344S277G0ZNIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UNIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5CONIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNANIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
GLYCERYL 1-STEARATEINACTIVE INGREDIENT258491E1RZNIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
HEXYLDECANOLINACTIVE INGREDIENT151Z7P1317NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JNIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFANIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
METHYLPROPANEDIOLINACTIVE INGREDIENTN8F53B3R4RNIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RNIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYNIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76458-333NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.]5Current NDC, Legacy NDC, 2 package rows20231215_fb4cc832-4cfd-4e29-a78e-ab848681a224.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 4 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERYNTH MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4c3bfa-32ec-c0dd-e063-6394a90ab15c2026-07-21WarningsExact identifier
application number: M006
OURUI ONE FACIAL BUMP REFINING ESSENCESALICYLIC ACID 0.25% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4959bb67-063f-ffa4-e063-6394a90aa01f2026-07-20WarningsExact identifier
application number: M006
Beilloso FACIAL BUMP REFINING ESSENCESALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4a461a7a-f5cf-6544-e063-6294a90a00f22026-07-20WarningsExact identifier
application number: M006
Lepnuns MILIA REMOVERDIDECYL DIMETHYL AMMONIUM CHLORIDE 0.025% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD497ed53c-2562-b370-e063-6294a90a5ba12026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Molecules, LLC44fa9eda-0910-7d70-e063-6394a90af3a72026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Moleculesdec189a2-5f93-7c3e-e053-2a95a90af9882026-07-20WarningsExact identifier
application number: M006
Clean and Clear Essentials Acne TonerSALICYLIC ACIDKenvue Brands LLC06cd03e3-6146-65d8-e063-6294a90a17012026-07-17WarningsExact identifier
application number: M006
24 Hour Acne SerumBENZOYL PEROXIDEDrmtlgy, LLC55507941-dbdf-4e5f-a74d-4da6f67b6a1f2026-07-17WarningsExact identifier
application number: M006
PCA Skin Acne Control Prebiotic CleanserSALICYLIC ACIDCP Skin Health Group, Inc.56bca675-3e59-815a-e063-6294a90a1d872026-07-16WarningsExact identifier
application number: M006
Acne patchesACNE PATCHESShenzhen Hengdasheng Technology Co., Ltd5664b9c4-6ae3-4f64-e063-6294a90a825a2026-07-14WarningsExact identifier
application number: M006
Zmztuhua Folliculitis Treatment CreamBENZOYL PEROXIDEGuangzhou Hechuang Commercial Service Co.,Ltd.567ceafc-b75a-9777-e063-6394a90ae1602026-07-13WarningsExact identifier
application number: M006
Magnilife Eczema CareSULFUR, GRAPHITE, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS WHOLEThe Magni Group, Inc.8e3fc743-4c82-4a03-a963-2d5f93a1bc262026-07-13WarningsExact identifier
application number: M006
PHYLA ACNE PHAGE SERUMSALICYLIC ACIDCOSMAX USA, CORP564abe82-c983-6a98-e063-6394a90a14a02026-07-10WarningsExact identifier
application number: M006
GOOD MOLECULE MAXIMUM STRENGHT ACNESALICYLIC ACIDCOSMAX USA, CORP564aafc0-1a06-1cba-e063-6294a90ae7382026-07-10WarningsExact identifier
application number: M006
Touch Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEDiractions Capital LLC1ae4e081-b04a-407d-992d-cd398f3afc542026-07-10WarningsExact identifier
application number: M006
Drs. ACNE SPOT TREATMENTSALICYLIC ACIDOL PHARMA TECH, LLC Drs. PHARMACY161b2306-364a-e1b8-e063-6394a90a6c882026-07-09WarningsExact identifier
application number: M006
Proactiv Acne Body WashSALICYLIC ACIDAlchemee, LLC36aef223-6a4a-433f-b292-631e6068b17f2026-07-08WarningsExact identifier
application number: M006
LadovernaBENZOYL PEROXIDE CREAMGuangzhou Oupeng Cosmetics Co., Ltd.55b0f9fd-9055-6969-e063-6294a90a1a7d2026-07-07WarningsExact identifier
application number: M006
L BRI KlearawaySALICYLIC ACIDL'BRI Health & Beautyb9aa1c48-b767-47b0-bb98-efb7e860ab362026-07-06WarningsExact identifier
application number: M006
L BRI Deep Clean TonerSALICYLIC ACIDL'BRI Health & Beauty607fb6d0-ae49-472c-9224-0673af934bd22026-07-06WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106309benzoyl peroxide 5 % Topical LotionPSNfb4cc832-4cfd-4e29-a78e-ab848681a2245
106309benzoyl peroxide 50 MG/ML Topical LotionSCDfb4cc832-4cfd-4e29-a78e-ab848681a2245
106309benzoyl peroxide 5 % Topical LotionSYfb4cc832-4cfd-4e29-a78e-ab848681a2245

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76458-333-02764580333021 BOTTLE in 1 CARTON (76458-333-02) / 59 mL in 1 BOTTLE1 bottle2012-07-150000-00-00NoNoCurrent