Bloomellee 14%Gel Azelaic Acid Cream

Product NDC: 87386-002
11-digit product format: 873860002
Labeler code: 87386
Product ID: 87386-002_534288ee-8c3d-cab9-e063-6294a90a24b6
Type: HUMAN OTC DRUG
Nonproprietary name: 14%Azelaic Acid
Dosage form: CREAM
Route: TOPICAL
Labeler: Shenzhen Lanxi Trading Co., Ltd.
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-05-25
Substance: AZELAIC ACID
Active strength: .14 g/g
Pharmacologic classes: Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	87386-002		D	Discontinued by firm		2026-10-05
excluded package	package	87386-002	87386-002-01	D	Discontinued by firm		2026-10-05

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: Bloomellee 14%Gel Azelaic Acid Cream
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZELAIC ACID	.14 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F2VW3D43YT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2738813	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
534252e4-9428-4cc7-e063-6394a90ae0fc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
91c62db0-0295-c81c-d10a-0856c259edd6	Product name	2	20200428
6c6fc281-9445-2e9e-1c29-a09ddbc4299c	Product name	2	20200213
d32bc2b8-0bb7-2216-87aa-24639646e202	Product name	3	20190619
2a856070-cbe7-4f85-be0f-09885ff91196	Product name	1	20150806

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bloomellee 14%Gel Azelaic Acid Cream	14%AZELAIC ACID	Shenzhen Lanxi Trading Co., Ltd.	534252e4-9428-4cc7-e063-6394a90ae0fc	2026-06-02	Warnings	Exact identifier ndc (product): 87386-002

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F2VW3D43YT	AZELAIC ACID	123-99-9	AZELAIC ACID

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
87386-002-01	87386000201	1 BOTTLE, DROPPER in 1 BOX (87386-002-01) / 40 g in 1 BOTTLE, DROPPER	2026-05-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
87386-002 Bloomellee 14%Gel Azelaic Acid Cream	Shenzhen Lanxi Trading Co., Ltd.	2026-06-02	HUMAN OTC DRUG LABEL	1