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

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 Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM
Rxcui106309

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

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