BenzoAzeline 10

Product NDC: 78863-1310
11-digit product format: 788631310
Labeler code: 78863
Product ID: 78863-1310_256eec2c-7298-46d3-93bc-e7c41375fd8a
Type: HUMAN OTC DRUG
Nonproprietary name: BENZOYL PEROXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Noon Aesthetics M.R. Ltd
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-03-01
Substance: BENZOYL PEROXIDE
Active strength: 1000 mg/mL
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: BenzoAzeline 10
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOYL PEROXIDE	1000 mg/mL

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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
985efa19-bd91-45cd-a2a0-d71ec325e51c	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
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
3f45980c-c196-47e5-0e5e-48b7c57327c5	Product name	5	20200428
6c6fc281-9445-2e9e-1c29-a09ddbc4299c	Product name	2	20200213
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810
2a856070-cbe7-4f85-be0f-09885ff91196	Product name	1	20150806
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78863-1310-1	BenzoAzeline 10	50 mL in 1 TUBE	CREAM	50	2
78863-1310-1	BenzoAzeline 10	1 in 1 CARTON	CREAM	1	2
78863-1310-2	BenzoAzeline 10	15 mL in 1 BOTTLE, PUMP	CREAM	15	2
78863-1310-2	BenzoAzeline 10	1 in 1 CARTON	CREAM	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78863-1310	BENZOAZELINE 10 (BENZOYL PEROXIDE) CREAM [NOON AESTHETICS M.R. LTD]	1	Current NDC, 4 package rows	20240301_985efa19-bd91-45cd-a2a0-d71ec325e51c.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 8 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceile tint PROTECT tinted serum SPF 50 Ivory	CEILE TINT PROTECT TINTED SERUM SPF 50 IVORY	LE COSMETICS INC	58547809-3480-1032-e063-6294a90a04c6	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium Deep	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEP	LE COSMETICS INC	58549160-3594-9056-e063-6394a90abf7d	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Deep	CEILE TINT PROTECT TINTED SERUM SPF 50 DEEP	LE COSMETICS INC	585498d4-b29c-9580-e063-6394a90adf1e	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Fair	CEILE TINT PROTECT TINTED SERUM SPF 50 FAIR	LE COSMETICS INC	58545633-cb36-6611-e063-6394a90a1f07	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Light	CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT	LE COSMETICS INC	5853ae6b-0eaf-e614-e063-6394a90ae91a	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Light Medium	CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUM	LE COSMETICS INC	585473c3-3ee9-7d84-e063-6394a90abd33	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM	LE COSMETICS INC	58547b48-251a-10eb-e063-6294a90ac95c	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium Tan	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TAN	LE COSMETICS INC	58547e38-ae84-82ee-e063-6394a90a27d6	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Tan	CEILE TINT PROTECT TINTED SERUM SPF 50 TAN	LE COSMETICS INC	58548331-38cd-8668-e063-6394a90a3362	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium Honey	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM HONEY	LE COSMETICS INC	5854861a-376d-8825-e063-6394a90a8aab	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Honey	CEILE TINT PROTECT TINTED SERUM SPF 50 HONEY	LE COSMETICS INC	585488c5-fac5-212f-e063-6294a90a00ff	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium Rich	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM RICH	LE COSMETICS INC	585488af-d14f-8d71-e063-6394a90ac4f0	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Rich	CEILE TINT PROTECT TINTED SERUM SPF 50 RICH	LE COSMETICS INC	58548e6d-9c82-249c-e063-6294a90a11ad	2026-08-05	Warnings	Exact identifier application number: M020
12 Days of Derm-Loved Skincare	OCTINOXATE, ZINC OXIDE, OATMEAL, BENZOYL PEROXIDE, AVOBENZONE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	a13f0275-5add-4464-88d4-ff9823274325	2026-08-03	Warnings	Exact identifier application number: M020
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY	OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%	Lale Cosmetics LLC	581fb0cd-c55d-d562-e063-6394a90a7f11	2026-08-03	Warnings	Exact identifier application number: M020
Manyo Air Light Moisturizing Sunscreen SPF 50	ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Manyo Factory Corp.	86761577-a32c-41a2-a2e3-b339b1493701	2026-08-03	Warnings	Exact identifier application number: M020
EltaMD UV Active	ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc	39d16479-d491-4c19-aa11-674461687c7b	2026-08-03	Warnings	Exact identifier application number: M020
AMBI SKINCARE Even and Clear Daily Facial Moisturizer SPF 30	OCTISALATE, OCTOCRYLENE, AVOBENZONE	AMBI Enterprises LLC	99bbe9a2-bb57-4a33-b339-1649d4b319c8	2026-07-31	Warnings	Exact identifier application number: M020
AMBI Even and Clear Facial Moisturizer SPF-30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	AMBI Enterprises LLC	4701c0ba-4ceb-4d66-9f99-515ce33b4648	2026-07-31	Warnings	Exact identifier application number: M020
Continuous Correction Cream	TITANIUM DIOXIDE	Baxter of California, LLC	1cbcc648-f2e1-af60-e063-6294a90ad4bb	2026-07-31	Warnings	Exact identifier application number: M020

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
78863-1310-1	78863131001	1 TUBE in 1 CARTON (78863-1310-1) / 50 mL in 1 TUBE	1 tube	2024-03-01	No	No	Current
78863-1310-2	78863131002	1 BOTTLE, PUMP in 1 CARTON (78863-1310-2) / 15 mL in 1 BOTTLE, PUMP		2024-03-01	No	No	Current