Home NDC 76458-333 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 76458-333 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 76458-333 76458-333-02 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…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 Ingredient Strength BENZOYL PEROXIDE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W9WZN9A0GM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106309 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76458-333-02 Nighttime Control 1 in 1 CARTON LOTION 1 5 76458-333-02 Nighttime Control 59 mL in 1 BOTTLE LOTION 59 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZOYL PEROXIDE ACTIVE INGREDIENT W9WZN9A0GM NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 BENZOYL PEROXIDE ACTIVE MOIETY W9WZN9A0GM NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT 59TL3WG5CO NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 CETEARYL GLUCOSIDE INACTIVE INGREDIENT 09FUA47KNA NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 GLYCERYL 1-STEARATE INACTIVE INGREDIENT 258491E1RZ NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 HEXYLDECANOL INACTIVE INGREDIENT 151Z7P1317 NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 HEXYLENE GLYCOL INACTIVE INGREDIENT KEH0A3F75J NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 METHYLPROPANEDIOL INACTIVE INGREDIENT N8F53B3R4R NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 POLYOXYL 20 CETOSTEARYL ETHER INACTIVE INGREDIENT YRC528SWUY NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76458-333 NIGHTTIME CONTROL (BENZOYL PEROXIDE) LOTION [CIRCADIA BY DR PUGLIESE, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20231215_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 7 of 55 · 1,088 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76458-333-02 76458033302 1 BOTTLE in 1 CARTON (76458-333-02) / 59 mL in 1 BOTTLE 1 bottle 2012-07-15 0000-00-00 No No Current