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 9 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Benzoyl Peroxide Wash Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0bb7c0-3c08-02cd-e063-6294a90a67492026-04-09WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0bb38a-765b-d072-e063-6294a90a8d4d2026-04-09WarningsExact identifier
application number: M006
ageLOC LumiSpa Treatment Cleanser AcneSALICYLIC ACIDNSE Products, Inc7f478ae8-8b97-4cdf-a023-cea14b992ff92026-04-03WarningsExact identifier
application number: M006
Anew Bare Acne Clearing Treatment 2% Salicylic AcidSALICYLIC ACIDTHE AVON COMPANY4e7d1429-0498-5812-e063-6394a90a4d4d2026-04-02WarningsExact identifier
application number: M006
UNBLEMISH 30-Day RegimenSALICYLIC ACID, BENZOYL PEROXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERodan & Fieldse9a52ccc-6ba0-4417-86cc-b2116a5b8d262026-04-01WarningsExact identifier
application number: M006
ageLOC LumiSpa Blemish SerumSALICYLIC ACIDNSE Products, Inc.35cdc16c-9a51-4ee9-b39d-36f29c4176ae2026-04-01WarningsExact identifier
application number: M006
UNBLEMISH Refining Acne WashSALICYLIC ACIDRodan & Fields08922efa-5a90-4dfb-b9f4-a6c4f8dba3c92026-03-31WarningsExact identifier
application number: M006
purity made simpleSALICYLIC ACIDPhilosophy, Inc.ed785dc1-a1a2-4e89-a4f7-2d0eef3ca2bb2026-03-31WarningsExact identifier
application number: M006
UNBLEMISH Dual Intensive Acne TreatmentBENZOYL PEROXIDERodan & Fields27ea743c-e080-487d-adc5-e31176f5b9fc2026-03-30WarningsExact identifier
application number: M006
SPESOLSKII MILIA REMOVER ESSENCESALICYLIC ACID 1% MILIA REMOVER ESSENCEBEST GREEN LIMITED4e35f848-2e9c-d0c6-e063-6294a90a8d4b2026-03-29WarningsExact identifier
application number: M006
Purito Acne Intensive TreatmentSALICYLIC ACIDHinature Inc.ca5ab57f-ddcb-4ced-8dd3-a698ad2d17de2026-03-26WarningsExact identifier
application number: M006
Oxy Vitamin C SerumSALICYLIC ACID 0.5%The Mentholatum Company2a34ceef-d442-1c2d-e063-6294a90a66392026-03-25WarningsExact identifier
application number: M006
Oxy Sensitive Skin Acne Cream CleanserBENZOYL PEROXIDE 5%The Mentholatum Company288da995-eda8-5d1c-e063-6394a90a38b22026-03-25WarningsExact identifier
application number: M006
Oxy Deep Pore Acne Cleansing PadsSALICYLIC ACIDThe Mentholatum Company4dde8b03-84e2-5ec7-e063-6394a90a69102026-03-25WarningsExact identifier
application number: M006
Rael Beauty Miracle Clear Complete Acne SerumSALICYLIC ACIDRael, Inc.fdb7ecd2-c4c8-90b6-e053-6294a90a69b12026-03-25WarningsExact identifier
application number: M006
JTOPYRTSALICYLIC ACID PADGuangzhou Yixiang Trading Co., Ltd.3dfb8f94-f734-de7d-e063-6394a90abed82026-03-25WarningsExact identifier
application number: M006
Tula Skincare Clear Skin Starters Travel Size Acne and Blemish Fighting KitSALICYLIC ACIDThe Procter & Gamble Manufacturing Company4dc9e3eb-c4d0-b5e1-e063-6394a90a9b7e2026-03-24WarningsExact identifier
application number: M006
Oxy 3-IN-1 Acne Cleansing PadsSALICYLIC ACIDThe Mentholatum Company4dcc9f0a-24d0-d62e-e063-6394a90aafe22026-03-24WarningsExact identifier
application number: M006
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREENZINC OXIDEENS KOREA Co., Ltd.34f9688d-efa1-1d3f-e063-6294a90ab1272026-03-23WarningsExact identifier
application number: M006
Flobow FACIAL BUMP REFINING ESSENCESALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4d6fb8af-5641-4a9a-e063-6294a90abfa92026-03-20WarningsExact 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