Therapeutic Hydrogel

Product NDC
78863-1090
11-digit product format
788631090
Labeler code
78863
Product ID
78863-1090_527a729b-d26e-4543-bb3f-3b82e116b0a1
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
CREAM
Route
TOPICAL
Labeler
Noon Aesthetics M.R. Ltd
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-01
Substance
SALICYLIC ACID
Active strength
1 g/50g
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
Therapeutic Hydrogel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID1 g/50g

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
317152Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cfe76456-0a4c-4dd8-b060-af9d109fb9b9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78863-1090-1Therapeutic Hydrogel50 g in 1 BOTTLE, DISPENSINGCREAM504
78863-1090-1Therapeutic Hydrogel1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78863-1090THERAPEUTIC HYDROGEL (SALICYLIC ACID) CREAM [NOON AESTHETICS M.R. LTD]3Current NDC, Legacy NDC, 2 package rows20240125_cfe76456-0a4c-4dd8-b060-af9d109fb9b9.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 28 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Earths Care Acne Spot TreatmentSULFURDLC Laboratories, Inc.85dab75e-5436-4e31-9ce2-c1995fde1dd92025-05-15WarningsExact identifier
application number: M006
Neutrogena On-the-Spot Acne Treatment Vanishing FormulaBENZOYL PEROXIDEKenvue Brands LLC7cc8f53d-b8e3-4711-a1d3-fd43be35af512025-05-12WarningsExact identifier
application number: M006
Biome-Balancing Clear and Prevent Acne (Blemish) Treatment SerumSALICYLIC ACIDMurad, LLC3709208a-5550-4819-b923-a883878737bb2025-05-05WarningsExact identifier
application number: M006
MY BEAUTY SPOT Day and Night Acne PatchSALICYLIC ACIDMELON BIO-TECH (THAILAND) CO., LTD.6e4ab3d3-378e-40e5-a6a5-66090edcfda82025-04-28WarningsExact identifier
application number: M006
Byoma Acne Control BodySALICYLIC ACIDByoma Ltd2ffedd29-b05d-485c-e063-6294a90a382b2025-04-23WarningsExact identifier
application number: M006
Byoma Acne Control MoisturizerSALICYLIC ACIDByoma Ltd300266fa-81fb-c26a-e063-6394a90abedf2025-04-23WarningsExact identifier
application number: M006
Byoma Acne Treatment SpotSALICYLIC ACIDByoma Ltd301673da-7202-49cf-e063-6294a90a520e2025-04-23WarningsExact identifier
application number: M006
Byoma Acne Clearing CleanserSALICYLIC ACIDByoma Ltd30036070-f5f1-c082-e063-6294a90a66e12025-04-23WarningsExact identifier
application number: M006
Neutrogena Body Clear Body WashSALICYLIC ACIDKenvue Brands LLC0d0cfe85-93ee-4815-a5c0-5995372227cc2025-04-18WarningsExact identifier
application number: M006
Dickinsons Original Witch Hazel Clarifying Foam CleanserSALICYLIC ACIDDickinson Brands Inc.63f30249-2a1f-403c-9bb3-8c0c4c9dde432025-04-10WarningsExact identifier
application number: M006
Aveeno Positively Radiant Clear Complexion Daily MoisturizerSALICYLIC ACIDKenvue Brands LLC3269c17c-7e3a-734c-e063-6294a90a15432025-04-10WarningsExact identifier
application number: M006
Neutrogena Clear Pore Oil-Eliminating AstringentSALICYLIC ACIDKenvue Brands LLC107ad1a9-0da7-4002-a40d-cee3764c6f6b2025-04-09WarningsExact identifier
application number: M006
CLARIFYING TONERSALICYLIC ACIDDrmtlgy, LLCcb94cf95-8954-43b4-84c9-9b1076949c992025-04-09WarningsExact identifier
application number: M006
TINGL EXFOLIATING PADSSALICYLIC ACIDDrmtlgy, LLCd81da185-69e0-41cf-850f-46a207aad0d62025-04-08WarningsExact identifier
application number: M006
Neutrogena All in 1 Acne Control Daily ScrubSALICYLIC ACIDKenvue Brands LLCae0fa680-6012-44c3-a1e8-a4d8d870a7212025-04-08WarningsExact identifier
application number: M006
Neutrogena Stubborn Body Acne TreatmentSALICYLIC ACIDKenvue Brands LLCdd1436c0-aa9e-259c-e053-2a95a90a0b4c2025-04-08WarningsExact identifier
application number: M006
TreeActiv Cystic Acne Spot TreatmentSULFURLeiluna LLCd1b81650-ccc4-49ed-9378-726b3a3a04c72025-04-08WarningsExact identifier
application number: M006
AHA BHA Blemish Control and Exfoliating SerumSALICYLIC ACID SERUMBanuskin, Inc.31e47495-a9fa-a9e8-e063-6294a90a6b672025-04-03WarningsExact identifier
application number: M006
Sulfur Spot TreatmentSULFUR ACNE TREATMENTBanuskin, Inc.31e527e0-ce37-e920-e063-6394a90ac8272025-04-03WarningsExact identifier
application number: M006
Shea MoistureNOURISHED AND RADIANT ACNE TREATMENT SERUM WITH 2% SALICYLIC ACIDConopco d/b/a/ Unilever31815039-5685-6b05-e063-6294a90a2a5e2025-03-29WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317152salicylic acid 2 % Topical CreamPSNcfe76456-0a4c-4dd8-b060-af9d109fb9b94
317152salicylic acid 20 MG/ML Topical CreamSCDcfe76456-0a4c-4dd8-b060-af9d109fb9b94
317152salicylic acid 2 % Topical CreamSYcfe76456-0a4c-4dd8-b060-af9d109fb9b94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
78863-1090-1788631090011 BOTTLE, DISPENSING in 1 CARTON (78863-1090-1) / 50 g in 1 BOTTLE, DISPENSING2020-05-010000-00-00NoNoCurrent