Home NDC 76354-416 Acne Calming Water Cream
Product NDC 76354-416
11-digit product format 763540416
Labeler code 76354
Product ID 76354-416_413498fc-ac69-96ac-e063-6394a90afeb9
Type HUMAN OTC DRUG
Nonproprietary name SALICYLIC ACID
Dosage form CREAM
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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only. When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Additional Listing Data#
Finished product Yes
Brand name base Acne Calming Water Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 10 mg/mL
Harmonized Identifiers# Field, Values table Field Values Unii O414PZ4LPZ Rxcui 417424
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76354-416-02 Blemish Control Basics Kit 1 in 1 CARTON CREAM 10 mg in 1mL 6 76354-416-02 Blemish Control Basics Kit 30 mL in 1 BOTTLE CREAM 30 mL 10 mg in 1mL 6 76354-416-01 Acne Calming Water Cream 50 mL in 1 BOTTLE CREAM 50 5 76354-416-01 Acne Calming Water Cream 1 in 1 CARTON CREAM 1 5 76354-416-02 Acne Calming Water Cream 1 in 1 CARTON CREAM 1 5 76354-416-02 Acne Calming Water Cream 30 mL in 1 BOTTLE CREAM 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76354-416 BLEMISH CONTROL BASICS KIT (SALICYLIC ACID) KIT [E.L.F. COSMETICS, INC] 5 Current NDC, Legacy NDC 20241108_1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d2.zip 76354-416 ACNE CALMING WATER CREAM (SALICYLIC ACID) CREAM [E.L.F. COSMETICS, INC.] 4 Current NDC, Legacy NDC, 4 package rows 20241108_01b70e53-9e24-4950-bbe9-c58905b6e68d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76354-416-01 76354041601 1 BOTTLE in 1 CARTON (76354-416-01) / 50 mL in 1 BOTTLE 1 bottle 2022-02-25 0000-00-00 No No Current 76354-416-02 76354041602 1 BOTTLE in 1 CARTON (76354-416-02) / 30 mL in 1 BOTTLE 1 bottle 2022-02-25 0000-00-00 No No Current