FDA.reportPublic FDA data

Acne Fighting Spot Gel

Product NDC
76354-414
11-digit product format
763540414
Labeler code
76354
Product ID
76354-414_41b43bda-b96f-5b9e-e063-6394a90ad8a9
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
e.l.f. Cosmetics, Inc
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-25
Substance
SALICYLIC ACID
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Acne Fighting Spot Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251380Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eca08910-58b9-4ce6-8e97-4b97c30784f5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76354-414-01Acne Fighting Spot Gel7.5 mL in 1 TUBEGEL7.56
76354-414-01Acne Fighting Spot Gel1 in 1 CARTONGEL16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76354-414ACNE FIGHTING SPOT GEL (SALICYLIC ACID) GEL [E.L.F. COSMETICS, INC]5Current NDC, Legacy NDC, 2 package rows20241108_eca08910-58b9-4ce6-8e97-4b97c30784f5.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 54 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne ControlCREAMWalgreenfc60cccb-405b-e49e-e053-6394a90a5a122023-09-11WarningsExact identifier
application number: M006
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
application number: M006
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
application number: M006
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
application number: M006
ACNE CLEANSINGSALICYLIC ACIDCLINIQUE LABORATORIES LLC7bae5802-cf51-4b41-9d7c-d72f1eb4c4af2023-08-30WarningsExact identifier
application number: M006
Gly-Sal 2-2 PadsSALICYLIC ACIDTopiderm, Inc.a92a9ffb-5c5b-43a4-b669-04667324920b2023-02-16WarningsExact identifier
application number: M006
Derma E Acne Clarifying MaskSULFURderma e55df8fb4-abc3-43fe-b89b-6e7d638b27a62023-02-14WarningsExact identifier
application number: M006
Replenix Acne Gly-Sal 2-2 Foaming CleanserSALICYLIC ACIDTopiderm, Inc.811dbf95-2b39-45c5-99a2-33c3c9d195702019-12-19WarningsExact identifier
application number: M006
REPLENIX ACNE SOLUTIONS WASHBENZOYL PEROXIDETopiderm, Inc.8dc2d27d-3cc4-4874-b4c2-32607849b2052019-12-17WarningsExact identifier
application number: M006
REPLENIX ACNE Solution BENZOYL PEROXIDE WASHBENZOYL PEROXIDETopiderm, Inc.235e9dd5-13f2-4078-9807-1d87fd9e6cba2019-12-17WarningsExact identifier
application number: M006
Replenix AcneBENZOYL PEROXIDETopiderm, Inc03d4c298-8f44-41f7-b086-96ae836152bb2019-10-31WarningsExact identifier
application number: M006
Replenix AcneBENZOYL PEROXIDETopiderm, Inc.c12f9005-a549-4447-9beb-df7126f77df12019-10-31WarningsExact identifier
application number: M006
Gly-Sal 10-2 PadsSALICYLIC ACIDTopiderm, Inc.b39e845d-4c40-4f9e-9cb5-a8386f3266522019-10-23WarningsExact identifier
application number: M006
Gly-Sal 5-2 PadsSALICYLIC ACIDTopiderm, Inc.e73bd26c-cdc2-47ab-94e8-3bc49a9b19e82019-10-22WarningsExact identifier
application number: M006
SKIN MEDICA Purifying Foaming WashSALICYLIC ACIDAllergan, Inc.064d9e2b-077f-4229-b653-666fc5479ae22013-03-01WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251380salicylic acid 1 % Topical GelPSNeca08910-58b9-4ce6-8e97-4b97c30784f56
251380salicylic acid 0.01 MG/MG Topical GelSCDeca08910-58b9-4ce6-8e97-4b97c30784f56
251380salicylic acid 1 % Topical GelSYeca08910-58b9-4ce6-8e97-4b97c30784f56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76354-414-01763540414011 TUBE in 1 CARTON (76354-414-01) / 7.5 mL in 1 TUBE1 tube2022-02-250000-00-00NoNoCurrent