PanOxyl

Product NDC
0316-0228
11-digit product format
003160228
Labeler code
0316
Product ID
0316-0228_48342795-9bf1-4541-e063-6394a90a10be
Type
HUMAN OTC DRUG
Nonproprietary name
benzoyl peroxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Crown Laboratories
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-03-25
Substance
BENZOYL PEROXIDE
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0316-0228DDiscontinued by firm2026-10-16
excluded packagepackage0316-02280316-0228-01DDiscontinued by firm2026-10-16
excluded packagepackage0316-02280316-0228-03DDiscontinued by firm2026-10-16
excluded packagepackage0316-02280316-0228-55DDiscontinued by firm2026-10-16

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0316-0228-55d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0316-0228-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0316-0228-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0316-0228-55f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0316-0228-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0316-0228-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0316-0228-552ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0316-0228-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0316-0228-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0316-0228-55a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0316-0228-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0316-0228-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0316-0228-55cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0316-0228-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0316-0228-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0316-0228-55cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0316-0228-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0316-0228-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0316-0228-55302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0316-0228-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0316-0228-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0316-0228-55ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0316-0228-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0316-0228-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0316-0228-550efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0316-0228-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0316-0228-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0316-0228-55ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0316-0228-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0316-0228-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0316-0228-55367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0316-0228-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0316-0228-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0316-0228-55557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0316-0228-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0316-0228-03557ba5c1ecfa…9c80585c8c6e…

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
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
142034Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1660f219-e789-91f1-e063-6294a90a7664Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-13Panoxyl Acne Creamy Wash
2023-02-13Panoxyl Acne Creamy Wash
2023-02-13Panoxyl Acne Creamy Wash
2023-01-30Panoxyl Acne Creamy Wash
2023-01-30Panoxyl Acne Creamy Wash
2023-01-30Panoxyl Acne Creamy Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0228-01PanOxyl1 in 1 CARTONCREAM14
0316-0228-01PanOxyl28 g in 1 TUBECREAM284
0316-0228-03PanOxyl85 g in 1 TUBECREAM854
0316-0228-55PanOxyl1 in 1 CARTONCREAM14
0316-0228-55PanOxyl156 g in 1 TUBECREAM1564

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0228-03GM - Gram0316-022866d86f14-d644-407d-9942-038916268d4212026-04-20
0316-0228-55GM - Gram0316-0228e1aa066d-1bdf-49c8-9517-ceebf274be2012019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0228PANOXYL (BENZOYL PEROXIDE) CREAM [CROWN LABORATORIES]2Current NDC, Legacy NDC, 5 package rows20240712_1660f219-e789-91f1-e063-6294a90a7664.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 27 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NAELI Exfoliator AHA BHA Face CleanserSALICYLIC ACIDALLI LLCe2a613c3-34f4-477e-99e6-67bcc7c117c42025-06-23WarningsExact identifier
application number: M006
Acne Treatment CreamACNE TREATMENT CREAMGuangzhou Yapeng Refinement Chemical Co., Ltd.37fc7d7f-da18-ac40-e063-6394a90abb5d2025-06-20WarningsExact identifier
application number: M006
Blemish Correcting SerumSALICYLIC ACIDTopiderm, Inc.84029bb8-a840-4b68-9a07-6838867332292025-06-17WarningsExact identifier
application number: M006
ACNE TREATMENT COTTON PADSACNE TREATMENT COTTON PADSGuangzhou Yapeng Refinement Chemical Co., Ltd.37ad7cd7-92df-82d9-e063-6294a90a0f042025-06-16WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION75e15ed6-e871-4dde-b7fc-145054626fa92025-06-12WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc2ac3a8c0-e0ed-435f-90fb-72c7a55a06732025-06-12WarningsExact identifier
application number: M006
Margarite Zinc CreamZINC CREAMRenu Laboratories, LLC3ca3b7d8-702a-036b-e054-00144ff8d46c2025-06-10WarningsExact identifier
application number: M006
Facial Cleansing WipesFACIAL CLEANSING WIPESShenzhen Shierjie Biological Engineering Co., LTD36f7677a-ec73-e677-e063-6294a90ad4802025-06-07WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incb36837e3-ea1c-41db-b52c-4175100895292025-06-05WarningsExact identifier
application number: M006
VENROCKSALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.349ae621-c832-128c-e063-6294a90a284d2025-06-05WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONbc9fffbc-c176-4d89-b1c6-294a8439a9302025-06-05WarningsExact identifier
application number: M006
Neutrogena Stubborn Acne AM TreatmentBENZOYL PEROXIDEKenvue Brands LLCd6e05b11-8c5f-490d-a5d8-116dcc895cb82025-06-04WarningsExact identifier
application number: M006
TULA SKINCARE BREAKOUT BREAKTHROUGH ACNE TONER PADSSALICYLIC ACIDThe Procter & Gamble Manufacturing Company36ada73d-cfc5-d4a4-e063-6294a90a7c732025-06-03WarningsExact identifier
application number: M006
Psoriasis Body WashCOLLOIDAL OATMEALRida LLC4b2bba1b-7e7b-4397-9eb4-d94c44b983142025-06-03WarningsExact identifier
application number: M006
Gly-Sal 10-2SALICYLIC ACIDTopiderm, Inc.4058327e-2764-4df0-9d5d-7cda72d9ca412025-06-02WarningsExact identifier
application number: M006
Dissolvable Microneedle Blemish PatchesSALICYLIC ACIDAdvaccine Biopharmaceuticals Suzhou Co., Ltd3640d29e-7e4c-b3be-e063-6394a90a0d9e2025-05-29WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Stress Control Triple Action TonerSALICYLIC ACIDKenvue Brands LLC36412939-97bc-6cb1-e063-6294a90aef482025-05-29WarningsExact identifier
application number: M006
Tula Skincare Clear It Up Acne Clearing and Tone Correcting GelSALICYLIC ACIDThe Procter & Gamble Manufacturing Company364a96fb-67fe-eeb7-e063-6394a90aa60c2025-05-29WarningsExact identifier
application number: M006
Psoriasis Scalp TreatmentSALICYLIC ACIDRida LLC14ab77e7-86b0-49d3-8efa-8a80c5a24d742025-05-28WarningsExact identifier
application number: M006
Aveeno Positively Radiant Clear Complexion Foaming CleanserSALICYLIC ACIDKenvue Brands LLCec136786-9d46-a022-e053-2a95a90a07522025-05-26WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN1660f219-e789-91f1-e063-6294a90a76644
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD1660f219-e789-91f1-e063-6294a90a76644
142034benzoyl peroxide 10 % Medicated Liquid SoapSY1660f219-e789-91f1-e063-6294a90a76644

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-0228-01003160228011 TUBE in 1 CARTON (0316-0228-01) / 28 g in 1 TUBE1 tube2022-10-12NoNoCurrent
0316-0228-030031602280385 g in 1 TUBE (0316-0228-03) 85 g2022-11-12NoNoCurrent
0316-0228-55003160228551 TUBE in 1 CARTON (0316-0228-55) / 156 g in 1 TUBE1 tube2018-12-010000-00-00NoNoCurrent