FDA.reportPublic FDA data

Acne Calming Water Cream

Product NDC
76354-416
Requested package NDC
76354-416-01
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

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 Calming Water Cream
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
417424Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
01b70e53-9e24-4950-bbe9-c58905b6e68dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
8234c772-5c41-424c-a33e-e06e8c4de9c1Product name220250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923bProduct name420250224
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76354-416-02Blemish Control Basics Kit1 in 1 CARTONCREAM10 mg in 1mL6
76354-416-02Blemish Control Basics Kit30 mL in 1 BOTTLECREAM30 mL10 mg in 1mL6
76354-416-01Acne Calming Water Cream50 mL in 1 BOTTLECREAM505
76354-416-01Acne Calming Water Cream1 in 1 CARTONCREAM15
76354-416-02Acne Calming Water Cream1 in 1 CARTONCREAM15
76354-416-02Acne Calming Water Cream30 mL in 1 BOTTLECREAM305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76354-416BLEMISH CONTROL BASICS KIT (SALICYLIC ACID) KIT [E.L.F. COSMETICS, INC]5Current NDC, Legacy NDC20241108_1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d2.zip
76354-416ACNE CALMING WATER CREAM (SALICYLIC ACID) CREAM [E.L.F. COSMETICS, INC.]4Current NDC, Legacy NDC, 4 package rows20241108_01b70e53-9e24-4950-bbe9-c58905b6e68d.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 1 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defense Acne Care 2% Salicylic AcidSALICYLIC ACID 2%Defense Soap LLC98fcc243-d789-181d-e053-2995a90a9b5d2026-09-09WarningsExact identifier
application number: M006
Jack Black Bump FixSALICYLIC ACIDJack Black, L.L.C.e8f51678-2675-405c-8462-351ec260051a2026-09-08WarningsExact identifier
application number: M006
Abib Acne foam cleanser Heartleaf foamSALICYLIC ACIDFourcompany Co., Ltd.5aa353ad-0ca5-77c1-e063-6394a90a62542026-09-04WarningsExact identifier
application number: M006
Dr.Leo Acne Buster Salicylic Acid DryingSALICYLIC ACIDDoctor Leo USA Inc5792fa71-eb6b-3c70-e063-6394a90abde82026-09-03WarningsExact identifier
application number: M006
Blackhead Clearing ScrugSALICYLIC ACIDWalmart Inc.6989591a-a78b-4971-baf2-51ebfaf9c7e72026-09-02Warnings, Adverse reactionsExact identifier
application number: M006
Beisitian FACIAL BUMP REFINING ESSENCESALICYLIC ACID 2% FACIAL BUMP REFINING ESSENCEWenzhou Yuyuan Pharmaceutical Co., Ltd.5a6784cd-93d3-aecc-e063-6294a90af0212026-09-01WarningsExact identifier
application number: M006
Folliculitis Treatment CreamBENZOYL PEROXIDEGuangzhou Hechuang Commercial Service Co.,Ltd.5a93f753-eb7d-ad11-e063-6294a90a67782026-09-01WarningsExact identifier
application number: M006
INVISIBLE ACNE PATCHESSALICYLIC ACID 0.5%Global America Group LLC1527e15f-472f-4e05-adb6-c2e561f503cf2026-08-31WarningsExact identifier
application number: M006
The Acne Spot TreatmentSALICYLIC ACID SPOTSpotless, Inc.4a1a3716-9eaf-6be4-e063-6294a90a31c32026-08-30WarningsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Your Military Exchanges57f06989-3ffa-4cd3-bde5-9d3cc639ac4d2026-08-28Warnings, Adverse reactionsExact identifier
application number: M006
Proactivplus Pore Clearing TreatmentSALICYLIC ACIDAlchemee, LLC334efe89-3775-5ddb-e063-6294a90ae3a82026-08-27WarningsExact identifier
application number: M006
GENTLE ACNE CLEANSERSALICYLIC ACIDDrmtlgy, LLC2abed972-3fae-4ef0-abb6-1883457e98be2026-08-26WarningsExact identifier
application number: M006
RAVN Mens Back AcneSALICYLIC ACIDNorth Forge Brands LLC4a512df2-4ad7-495c-868a-1f4d0a8863912026-08-26WarningsExact identifier
application number: M006
Salicylic Acid Body WashSALICYLIC ACIDGuangdong Danlan International Biotechnology Co., Ltd59d671e7-7bbc-a963-e063-6394a90a776f2026-08-24WarningsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDWalmart Inc.5a76498e-a6f6-4e04-a2c7-245be947b0062026-08-21Warnings, Adverse reactionsExact identifier
application number: M006
Acne Treatment CreamBENZOYL PEROXIDECVS Healthaef82711-e3c3-439d-adda-542933ff44202026-08-19WarningsExact identifier
application number: M006
Tula Skincare Acne Heroes Acne Clearing KitSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5967255f-b511-9c7f-e063-6294a90a3e632026-08-19WarningsExact identifier
application number: M006
BYT BANGYTONG MILIA REMOVERSALICYLIC ACID 2% MILIA REMOVERShenzhen Jindali Technology Co., Ltd596a2471-d07c-14a5-e063-6394a90a4fcc2026-08-19WarningsExact identifier
application number: M006
RFA Clear and Calm Balancing SerumSALICYLIC ACIDTopiderm, Inc.f63f2c89-3567-4b08-be51-3fdfc5e0b1ba2026-08-14WarningsExact identifier
application number: M006
WART REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD58e901b8-66e0-d2d6-e063-6394a90ae6012026-08-13WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2593955{1 (30 ML) (salicylic acid 10 MG/ML Medicated Liquid Soap) / 1 (30 ML) (salicylic acid 10 MG/ML Topical Cream) } PackGPCK1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d26
1038982salicylic acid 1 % Medicated Liquid SoapPSN1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d26
2593955salicylic acid 1 % Medicated Liquid Soap (30 ML) / salicylic acid 1 % Topical Cream (30 ML) PackPSN1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d26
417424salicylic acid 1 % Topical CreamPSN1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d26
1038982salicylic acid 10 MG/ML Medicated Liquid SoapSCD1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d26
417424salicylic acid 10 MG/ML Topical CreamSCD1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d26
1038982salicylic acid 1 % Medicated Liquid SoapSY1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d26
2593955salicylic acid 1 % Medicated Liquid Soap (30 ML) / salicylic acid 1 % Topical Cream (30 ML) PackSY1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d26
417424salicylic acid 1 % Topical CreamSY1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d26
417424salicylic acid 1 % Topical CreamPSN01b70e53-9e24-4950-bbe9-c58905b6e68d5
417424salicylic acid 10 MG/ML Topical CreamSCD01b70e53-9e24-4950-bbe9-c58905b6e68d5
417424salicylic acid 1 % Topical CreamSY01b70e53-9e24-4950-bbe9-c58905b6e68d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76354-416-01763540416011 BOTTLE in 1 CARTON (76354-416-01) / 50 mL in 1 BOTTLE1 bottle2022-02-250000-00-00NoNoCurrent