FDA.reportPublic FDA data

Walgreens Acne Spot Treatment

Product NDC
0363-0116
11-digit product format
003630116
Labeler code
0363
Product ID
0363-0116_243acaab-01bb-dcdc-e063-6394a90afcf1
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
LOTION
Route
TOPICAL
Labeler
WALGREEN COMPANY
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-19
Substance
BENZOYL PEROXIDE
Active strength
25 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Walgreens Acne Spot Treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE25 mg/g

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
200009Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f12d432e-3115-47ec-e053-2a95a90a69d3Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0116-51Walgreens Acne Spot Treatment21 g in 1 TUBELOTION212
0363-0116-51Walgreens Acne Spot Treatment1 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0116WALGREENS ACNE SPOT TREATMENT (BENZOYL PEROXIDE) LOTION [WALGREEN COMPANY]2Current NDC, Legacy NDC, 2 package rows20241013_f12d432e-3115-47ec-e053-2a95a90a69d3.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 44 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MDacne Body Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEMDAlgorithms Inc97529268-c45c-49c0-8eb0-15c90def69ea2024-09-19WarningsExact identifier
application number: M006
MDacne Customized Acne Cleanser Hydrating Salicylic AcidSALICYLIC ACIDMDAlgorithms Incff01a623-327d-4350-819f-68188c82b9122024-09-19WarningsExact identifier
application number: M006
Aveeno clear complexion daily moisturizerSALICYLIC ACIDKenvue Brands LLCc13dac31-bccb-4fcc-81c4-90e3e63ba59f2024-09-12WarningsExact identifier
application number: M006
MY BEAUTY SPOT Acne Care Patch KitSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.9bec6363-bc71-47fa-8732-33fa7cc58d6c2024-09-10WarningsExact identifier
application number: M006
Healing Acne Care Patches - Tea Tree and Vitamin ASALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.ad7e5be5-7e20-4616-8094-8dae43cfc0052024-09-10WarningsExact identifier
application number: M006
Healing Acne Care Patches - Tea Tree and Salicylic AcidSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.ec37a585-3adb-4829-93d1-7814adbdc0962024-09-10WarningsExact identifier
application number: M006
Spot Acne Treatment Oil Free 0.75ozSALICYLIC ACID CREAMChina Ningbo Shangge Cosmetics Technology Corp.21cedce7-61e0-6479-e063-6294a90abf5d2024-09-10WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEBryant Ranch Prepack4ea1d07e-b39f-4afb-85ae-0b3c544ac3c72024-09-06WarningsExact identifier
application number: M006
Spot Acne Treatment Oil Free 0.75ozSALICYLIC ACIDRejoice International Corp.212f77ca-82d3-6a78-e063-6394a90aed322024-09-02WarningsExact identifier
application number: M006
HEALING BLEMISH DOTSSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.4e62aee6-978d-4439-83cd-ee24882450e72024-08-28WarningsExact identifier
application number: M006
amazon basics step 3 treatment Acne medicationBENZOYL PEROXIDEAMAZON.COM SERVICES LLCe104ea51-816c-4565-a829-b03957d3d9622024-08-28WarningsExact identifier
application number: M006
amazon basics step 1 cleanser Acne treatmentBENZOYL PEROXIDEAMAZON.COM SERVICES LLC23a060f0-d379-4370-9a79-ca6e854419b42024-08-26WarningsExact identifier
application number: M006
SEYTU SpotSALICYLIC ACIDOmnilife USA, Inc.68252aa0-36cd-4380-8898-16a5e47318662024-08-23WarningsExact identifier
application number: M006
Peach Slices 3 Step Acne Starter KitSALICYLIC ACIDPeach & Lily, Inc0c8860ca-5376-4e98-a7a9-4668dff4f0aa2024-08-14WarningsExact identifier
application number: M006
PHARMA CLEAR CLEANSERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCd2c39d80-5ccd-43a8-a8bf-eba502bfdbf12024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR MOISTURIZERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCc4c08475-bafa-4bb1-92a5-e94e600862642024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR ACNE TREATMENTSALICYLIC ACIDPHARMAGEL INTERNATIONAL INC6d94f911-d751-45e4-b24d-8d85c6a3cefb2024-08-13WarningsExact identifier
application number: M006
Anti-Everything Face SerumSALICYLIC ACID SERUMBentley laboratories, llC8330e61c-50ec-44a5-91d9-a97e5a9d03882024-08-05WarningsExact identifier
application number: M006
Anti-Everything Face MoisturizerSALICYLIC ACID CREAMBentley Laboratories, LLC36cb28f2-2620-4b88-811f-a2d6c1e22e792024-08-05WarningsExact identifier
application number: M006
Tucks Medicated Cooling PadsWITCH HAZELBlistex Inc1eb3c742-7104-7b47-e063-6394a90a84ba2024-08-02WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200009benzoyl peroxide 2.5 % Topical LotionPSNf12d432e-3115-47ec-e053-2a95a90a69d32
200009benzoyl peroxide 25 MG/ML Topical LotionSCDf12d432e-3115-47ec-e053-2a95a90a69d32
200009benzoyl peroxide 2.5 % Topical LotionSYf12d432e-3115-47ec-e053-2a95a90a69d32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0116-51003630116511 TUBE in 1 CARTON (0363-0116-51) / 21 g in 1 TUBE1 tube2019-01-190000-00-00NoNoCurrent