FDA.reportPublic FDA data

Tiege Hanley

Product NDC
71714-003
11-digit product format
717140003
Labeler code
71714
Product ID
71714-003_5d3058d4-560c-05ea-e063-6294a90aff65
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
CREAM
Route
TOPICAL
Labeler
Tiege Hanley
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
Substance
SALICYLIC ACID
Active strength
20 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
Tiege Hanley
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID20 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71714-003-24Tiege Hanley24 mL in 1 BOTTLE, DISPENSINGCREAM242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71714-003TIEGE HANLEY (SALICYLIC ACID) CREAM [TIEGE HANLEY]1Current NDC, 1 package rows20240901_1c1414ad-ba5f-51cc-e063-6294a90a66fb.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 52 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne Fighting Spot with Aloe clearSALICYLIC ACIDZhejiang Ayan Biotech Co.,Ltd.db0054b1-29b9-48fa-8a02-86683bae81342023-11-21WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Clarifying Acne CleanserSALICYLIC ACIDGalderma Laboratories, L.P.9add83f2-7da6-4cd0-b91b-f6c937a562552023-11-20WarningsExact identifier
application number: M006
Dr. Gross AB Acne Daily BreakoutSALICYLIC ACIDTopiderm, Inc79d7f1f6-d08f-4be0-afc1-9ab4338a954d2023-11-20WarningsExact identifier
application number: M006
Dr. Dennis Gross Alpha Beta On the Spot EliminatorSALICYLIC ACIDTopiderm, Ince0dccdbc-56fd-4034-b479-f2a2ebde22342023-11-16WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Triple-Action Acne SerumSALICYLIC ACIDGalderma Laboratories, L.P.3e6eb59f-c523-460e-87ed-750b4a8cacac2023-11-16WarningsExact identifier
application number: M006
Medicated WashSALICYLIC ACIDVivier Pharma, Inc.e90ab8b6-6a77-4e02-9d71-45cd7383cb0a2023-11-14WarningsExact identifier
application number: M006
GOODBYE ACNE Complete treatment gelSALICYLIC ACIDPeter Thomas Roth, LLC09b88031-f5fe-8ae1-e063-6394a90a8a6a2023-11-14WarningsExact identifier
application number: M006
L BRI Pure n Natural Deep Clean TonerSALICYLIC ACIDL'BRI HEALTH AND BEAUTY INC353e948e-da5d-4c15-adcb-77ef978cf05f2023-11-11WarningsExact identifier
application number: M006
MD-Acne Body Acne TreatmentBENZOYL PEROXIDEMD Algorithms Inc.97981e9b-d56a-42f6-a75f-647b4732021e2023-11-11WarningsExact identifier
application number: M006
ACNE THERAPYBENZOYL PEROXIDEmenScience Androceuticals, LLC4dec259d-200e-44f2-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M006
HUMANE Acne Spot TreatmentBENZOYL PEROXIDEApprendista, LLCceeb398e-c516-45e4-a21c-cbecf6206fcc2023-11-11WarningsExact identifier
application number: M006
VANIBISS BUTT and THIGHS Acne Treatment CreamSALICYLIC ACIDVanibiss Inca0a75b54-e484-4e89-bdf2-e2c864cd27342023-11-11WarningsExact identifier
application number: M006
SIMPLY VITAL Acne Face CreamSALICYLIC ACIDALPHA PLANTS INC67c43d4a-873c-4b8e-83ff-6485d9633e7b2023-11-11WarningsExact identifier
application number: M006
CLARIFAST One Step Acne TreatmentSALICYLIC ACIDVIREO SYSTEMS, INC.b20a0f00-4bf2-4583-b399-7097542fff902023-11-11WarningsExact identifier
application number: M006
5 Percent Benzoyl Peroxide CleanserBENZOYL PEROXIDEBrand Evangelists for Beauty Limitede82469e2-606a-4263-9aaa-08596b59ff6b2023-11-10WarningsExact identifier
application number: M006
The INKEY List Acne Clearing MoisturizerSULFURBrand Evangelists for Beauty Limitedd26f5031-6592-4467-afc9-41c21f9f048c2023-11-10WarningsExact identifier
application number: M006
ACNE FORTE Acne Treatment CreamBENZOYL PEROXIDEGSCM Ventures Inc. DBA Revitolc29ed6c1-b8ad-4131-a94c-379f16ab2ee52023-11-10WarningsExact identifier
application number: M006
Meijer Blackhead Clearing Scrub Acne medicationSALICYLIC ACIDMeijer Distribution, Inc338e8937-e17e-4e14-b18f-2e63f55314422023-11-08WarningsExact identifier
application number: M006
Acne Fighting Foundation CaramelSALICYLIC ACIDZhejiang Ayan Biotech Co.,Ltd.92c4fe5f-fcc8-4dde-9f34-a55f53e009bb2023-11-06WarningsExact identifier
application number: M006
Asepxia Neutral Acne BarSALICYLIC ACIDGenomma Lab USAb3995e68-d364-4d96-8148-b456087b42972023-11-06WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317152salicylic acid 2 % Topical CreamPSN1c1414ad-ba5f-51cc-e063-6294a90a66fb2
317152salicylic acid 20 MG/ML Topical CreamSCD1c1414ad-ba5f-51cc-e063-6294a90a66fb2
317152salicylic acid 2 % Topical CreamSY1c1414ad-ba5f-51cc-e063-6294a90a66fb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71714-003-247171400032424 mL in 1 BOTTLE, DISPENSING (71714-003-24) 24 ml2024-09-01NoNoCurrent