PanOxyl Acne Clearing Spot Treatment

Product NDC
0316-0298
11-digit product format
003160298
Labeler code
0316
Product ID
0316-0298_50715555-1b9b-2217-e063-6394a90ac318
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Crown Laboratories
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-01
Substance
BENZOYL PEROXIDE
Active strength
100 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
PanOxyl Acne Clearing Spot Treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE100 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
486131Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
507150a0-9c20-4a2e-e063-6394a90ab9c7Available 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

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 49 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CeraVe Developed with Dermatologists Acne Control CleanserSALICYLIC ACIDL'Oreal USA Products Inc00203b2a-74dd-45a5-977a-3ef4eb3145772023-12-31WarningsExact identifier
application number: M006
La Roche Posay Laboratorie Dermatologique Effaclar Medicated CleanserSALICYLIC ACIDL'Oreal USA Products Inc8a6e2634-2497-403a-af03-113bf35fe36a2023-12-31WarningsExact identifier
application number: M006
CeraVe Acne Foaming CleanserBENZOYL PEROXIDEL'Oreal USA Products Incd9c11b75-14ee-46e3-9b1d-c349a102e2fd2023-12-31WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Acne TreatmentBENZOYL PEROXIDEL'OREAL USA, INC.8ed6ee51-816e-4c83-a437-4ceaa339b1302023-12-31WarningsExact identifier
application number: M006
CeraVe Developed with Dermatologists Acne Control Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc2532352e-eabc-4565-9437-b8801db6937a2023-12-31WarningsExact identifier
application number: M006
Kiehls Since 1851 Blue Herbal Acne Cleanser Treatment with Frankincense and Ginger RootSALICYLIC ACIDL'Oreal USA Products Incd8ad899b-a4d9-4720-aa37-b35d95ff899c2023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot TreatmentSULFURL'Oreal USA Products Inc217c697e-0260-46d5-a202-ce7345eadd942023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating and PreventingSALICYLIC ACIDL'Oreal USA Products Inc14429a1d-7db9-49a7-85d6-22374d03ecaa2023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Truly Targeted Acne Clearing SolutionSALICYLIC ACIDL'Oreal USA Products Inc55f614ee-f0fb-425d-aa5e-f90cad51c2852023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Blue Herbal Acne Cleanser TreatmentSALICYLIC ACIDL'Oreal USA Products Inc09e7f362-6187-4e49-b703-8249c70e51242023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Breakout Control Acne Treatment FacialSALICYLIC ACIDL'Oreal USA Products Inc3346f5f8-5793-47f6-8e71-250d3cc05c0d2023-12-30WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm SOS Acne Rescue Spot CorrectorSULFURL'Oreal USA Products Inc4907bc52-62e3-4256-b4ca-bcde896a4aab2023-12-27WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula PadsSALICYLIC ACIDL'Oreal USA Products Incbc0d1691-c13d-4c15-8c44-ecee30cb0ae22023-12-27WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula CleanserSALICYLIC ACIDL'Oreal USA Products Inc935a58f0-d9a3-4423-9a5f-65fd19fad3db2023-12-27WarningsExact identifier
application number: M006
All Acne TreatmentSALICYLIC ACIDBlaine Labs Inc.ee85939e-64fc-4b18-af5b-6ebd7e14e5722023-12-21WarningsExact identifier
application number: M006
In the Clear Acne SerumSALICYLIC ACIDThe Honest Company, Incdc9e0545-43af-3d27-e053-2a95a90a52492023-12-19WarningsExact identifier
application number: M006
Spot Stopper Acne Spot TreatmentSALICYLIC ACIDThe Honest Company, Incdc7afebd-e212-b9ff-e053-2a95a90a15a52023-12-19WarningsExact identifier
application number: M006
Get Clarity Foaming Acne CleanserSULFURThe Honest Company, Incdd948b1b-d71c-1a89-e053-2a95a90a87192023-12-19WarningsExact identifier
application number: M006
Acne Med 10%BENZOYL PEROXIDEFace Reality, LLC45ad7429-ccd0-28f6-e054-00144ff88e882023-12-15WarningsExact identifier
application number: M006
Acne Face and BodyBENZOYL PEROXIDEFace Reality, Inc.454983d2-4b00-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0316-0298-01003160298011 TUBE in 1 CARTON (0316-0298-01) / 28 g in 1 TUBE1 tube2026-06-01NoNoCurrent