PanOxyl

Product NDC: 0316-0228
Requested package NDC: 0316-0228-55
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0316-0228	0316-0228-55	D	Discontinued by firm		2026-10-27

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`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
Ingredient	Strength
BENZOYL PEROXIDE	100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W9WZN9A0GM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
142034	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
1660f219-e789-91f1-e063-6294a90a7664	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
d9d61457-6a5a-41fc-b418-e5479a2904b7	Product name	2	20230303
32012d5c-25ac-49c7-9d4c-1313177fff7c	Product name	1	20230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
3f45980c-c196-47e5-0e5e-48b7c57327c5	Product name	5	20200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0316-0228-01	PanOxyl	1 in 1 CARTON	CREAM	1	4
0316-0228-01	PanOxyl	28 g in 1 TUBE	CREAM	28	4
0316-0228-03	PanOxyl	85 g in 1 TUBE	CREAM	85	4
0316-0228-55	PanOxyl	1 in 1 CARTON	CREAM	1	4
0316-0228-55	PanOxyl	156 g in 1 TUBE	CREAM	156	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0316-0228-03	GM - Gram	0316-0228	66d86f14-d644-407d-9942-038916268d42	1	2026-04-20
0316-0228-55	GM - Gram	0316-0228	e1aa066d-1bdf-49c8-9517-ceebf274be20	1	2019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0316-0228	PANOXYL (BENZOYL PEROXIDE) CREAM [CROWN LABORATORIES]	2	Current NDC, Legacy NDC, 5 package rows	20240712_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 47 of 54 · 1,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Creamy Acne Face Wash Acne Medication	BENZOYL PEROXIDE	Walgreen Company	13e5396b-839b-4c08-a98f-f0a36c9a0bff	2024-05-09	Warnings	Exact identifier application number: M006
Bubble Knock Out Acne Spot Treatment	SALICYLIC ACID	BUBBLE BEAUTY	17cf44cf-55f1-86a5-e063-6294a90a35d2	2024-05-06	Warnings	Exact identifier application number: M006
Bubble Super Clear Blemish Prevention Serum	SALICYLIC ACID	BUBBLE BEAUTY	1790ad12-c947-ddc0-e063-6394a90a8569	2024-05-03	Warnings	Exact identifier application number: M006
Walgreens Daily Acne Cleanser- Sensitive Skin Formula	BENZOYL PEROXIDE	Walgreen Company	acae5006-e647-4f00-b93a-2c0bceee14cb	2024-05-01	Warnings	Exact identifier application number: M006
Derma E Acne Blemish Control Treatment Serum	SALICYLIC ACID	derma e	bf5f489d-07c6-47b8-ae76-701e7ad92e8d	2024-04-30	Warnings	Exact identifier application number: M006
Pacifica Clear Mist Facial Acne	SALICYLIC ACID	Pacifica Beauty, LLC	16ee1a80-d523-1d02-e063-6394a90a9459	2024-04-25	Warnings	Exact identifier application number: M006
Benzoyl Peroxide	BENZOYL PEROXIDE	Burel Pharmaceuticals, LLC	0617d42d-511d-4c1a-a919-b37abbc14efc	2024-04-24	Warnings	Exact identifier application number: M006
Blemish Dots	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	f3cd004d-32f1-4888-8129-d355a4750b25	2024-03-24	Warnings	Exact identifier application number: M006
Lacura Blemish Dots Conceal and Treat	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	15c447b5-0e51-43e7-b697-683bc0e686c0	2024-03-20	Warnings	Exact identifier application number: M006
My Beauty Spot Acne Buster	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	c61e100b-a141-45b3-842b-855be28b0226	2024-03-20	Warnings	Exact identifier application number: M006
My Beauty Spot Acne Buster	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	f5c5a2df-11c5-4134-bf1f-b50564216449	2024-03-20	Warnings	Exact identifier application number: M006
Blemish Control Dots aloe vera	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	4722ff71-7d9f-4ef2-9f8b-3614e80b864f	2024-03-20	Warnings	Exact identifier application number: M006
Blemish Control Dots	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	dc5410d0-d9f0-4ea4-b587-8bdfc39ac92b	2024-03-20	Warnings	Exact identifier application number: M006
Blemish Dots	SALICYLIC ACID 0.5%	Ganzhou Olivee Cosmetic Co., Ltd.	ca0e6b50-2995-41f8-b944-9f166aac0511	2024-03-13	Warnings	Exact identifier application number: M006
Maximum Sterngth Cleansing Pads Equate	SALICYLIC ACID	Walmart	7db929b6-6470-4840-b016-7e19688548dd	2024-03-11	Warnings	Exact identifier application number: M006
Acne Body Wash	SALICYLIC ACID	Rejoice International	97369cca-735a-425f-a0bc-00bc07691465	2024-02-28	Warnings	Exact identifier application number: M006
Oil-Free Foaming Acne Wash Facial Cleanser Grapefruit	SALICYLIC ACID	Rejoice International	a31baa57-1dfd-44d6-87a5-1b06377cb8b9	2024-02-28	Warnings	Exact identifier application number: M006
Oil-Free Foaming Acne Wash Facial Cleanser Tea Tree Oil	SALICYLIC ACID	Rejoice International	7ae434d1-8b07-4121-9163-df07598d4156	2024-02-28	Warnings	Exact identifier application number: M006
XtraCare Deep Cleaning Astringent	SALICYLIC ACID	Rejoice International	20cb8584-8a31-40a8-8a47-d9fa8ec8abcf	2024-02-28	Warnings	Exact identifier application number: M006
The INKEY List Beta Hydroxy Acid Serum	SALICYLIC ACID	Brand Evangelists for Beauty Ltd	d554920f-e33a-484b-bbd8-513715616384	2024-02-26	Warnings	Exact identifier application number: M006

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W9WZN9A0GM	BENZOYL PEROXIDE	94-36-0	BENZOYL PEROXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
142034	benzoyl peroxide 10 % Medicated Liquid Soap	PSN	1660f219-e789-91f1-e063-6294a90a7664	4
142034	benzoyl peroxide 100 MG/ML Medicated Liquid Soap	SCD	1660f219-e789-91f1-e063-6294a90a7664	4
142034	benzoyl peroxide 10 % Medicated Liquid Soap	SY	1660f219-e789-91f1-e063-6294a90a7664	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0316-0228-55	00316022855	1 TUBE in 1 CARTON (0316-0228-55) / 156 g in 1 TUBE	1 tube	2018-12-01	0000-00-00	No	No	Current