CVS Health MAXIMUM STRENGTH Therapeutic Dandruff

Product NDC
51316-443
11-digit product format
513160443
Labeler code
51316
Product ID
51316-443_3d0848e5-4fd5-4051-82b9-39b6734f2aca
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
CVS Health
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-28
Substance
SALICYLIC ACID
Active strength
30 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
CVS Health MAXIMUM STRENGTH Therapeutic Dandruff
Brand name suffix
Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID30 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
205023Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bd32def7-b002-4e12-89ad-b7d13754d82aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-443-01CVS Health MAXIMUM STRENGTH Therapeutic DandruffAnti-dandruff, anti-seborrheic dermatitis, anti-psoriasis133 mL in 1 BOTTLESHAMPOO1332
51316-443-01CVS Health MAXIMUM STRENGTH Therapeutic DandruffAnti-dandruff, anti-seborrheic dermatitis, anti-psoriasis1 in 1 CARTONSHAMPOO12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-443CVS HEALTH MAXIMUM STRENGTH THERAPEUTIC DANDRUFF ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS (SALICYLIC ACID) SHAMPOO [CVS HEALTH]1Current NDC, 2 package rows20240926_bd32def7-b002-4e12-89ad-b7d13754d82a.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 26 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
As I Am Dry and Itchy Scalp CarePYRITHIONE ZINCSalon Commodities, Inc.71ea4820-4160-41c2-e053-2a95a90a127d2024-10-09WarningsExact identifier
application number: M032
As I Am Dry and Itchy Scalp Care Co WashPYRITHIONE ZINCSalon Commodities, Inc.71edee79-87ed-ff7c-e053-2995a90ae1302024-10-09WarningsExact identifier
application number: M032
Vanicream Z-BarPYRITHIONE ZINCPharmaceutical Specialties, Inc.21c84000-5d08-ae53-e063-6294a90a23622024-10-03WarningsExact identifier
application number: M032
Head and Shoulders Classic Clean DandruffPYRITHIONE ZINCNavajo Manufacturing Company Inc3886d51a-b946-4862-a237-e8232df956372024-10-02WarningsExact identifier
application number: M032
CVS Daily Dandruff Anti-dandruffPYRITHIONE ZINCCVS Health705f5ced-a245-42c8-a32f-baaddaa11c6e2024-09-27WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDCVS Healthbd32def7-b002-4e12-89ad-b7d13754d82a2024-09-24WarningsExact identifier
application number: M032
ndc (product): 51316-443
CVS Health MAXIMUM STRENGTH Dandruff Anti-Seborrheic Dermatitis, anti-dandruffSELENIUM SULFIDECVS Healthcff51af6-84de-4ba5-ac99-9bc42a65c9a52024-09-24WarningsExact identifier
application number: M032
VERB PRODUCTS Balance Relief Salicylic Acid Dandruff Clinical StrengthSALICYLIC ACIDVerb Products Inc.18bddd16-e001-445c-9647-801defc1d5272024-09-03WarningsExact identifier
application number: M032
Denorex Severe ItchCOAL TARNeoteric Cosmetics, Inc.213ccbc4-2f52-58b6-e063-6294a90ae2482024-09-03WarningsExact identifier
application number: M032
SORARESALSALICYLIC ACIDSummer Herbal Inc.af734362-057b-4011-bf4e-c4e4dd67f68c2024-09-03WarningsExact identifier
application number: M032
ion 2 in 1 anti-dandruff Anti-dandruffPYRITHIONE ZINCArcadia Beauty Labs LLC38631b45-b222-4a25-8180-25970dabdffc2024-08-28WarningsExact identifier
application number: M032
TopCare Therapeutic Anti-Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARTopco Associates LLC070a5249-0b37-4b7f-a55b-609a0d8504d22024-08-22WarningsExact identifier
application number: M032
J1003005 Jason Dandruff ReliefSULFUR, SALICYLIC ACIDThe Hain Celestial Group, Inc.625e8306-78c4-3317-e053-2991aa0afe812024-07-31WarningsExact identifier
application number: M032
Jason Dandruff Relief Treatment 2 in 1ZINC PYRITHIONEThe Hain Celestial Group, Inc4afa1048-7a76-4562-8dcf-9252d5bfa48a2024-07-31WarningsExact identifier
application number: M032
Alba Natural Acnedote AstringentSALICYLIC ACIDThe Hain Celestial Group, Inc.939f90e7-e1de-4ca3-a484-90f1b87797d62024-07-31WarningsExact identifier
application number: M032
Matrix Biolage ScalpSync AntidandruffPYRITHIONE ZINCL'Oreal USA Products Inc8564f2cf-b680-4e2c-8451-f345c9852c1a2024-07-18WarningsExact identifier
application number: M032
Pete and Pedro Control Anti Itch DandruffCOAL TARPETE AND PEDRO LLC34ec83c1-31b9-4ecc-8bd2-898fd85364ba2024-07-02WarningsExact identifier
application number: M032
VICHY LABORATOIRES DERCOS Selenium Sulfide Anti-DandruffSELENIUM SULFIDE, MICRONIZEDL'Oreal USA Products Incdeae26e0-53f0-442b-959c-0f925a102db02024-06-25WarningsExact identifier
application number: M032
VICHY LABORATOIRES Dercos Selenium Sulfide Anti-dandruffSELENIUM SULFIDE, MICRONIZEDPRODUCTOS CAPILARES L'OREAL SA3fcb03fc-552a-4b02-981e-2ff84142da962024-06-25WarningsExact identifier
application number: M032
Dercos Salicylic Acid Anti-Dandruff SerumSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SA024f9299-ee6c-48e3-89e7-96b7db060c302024-06-20WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205023salicylic acid 3 % Medicated ShampooPSNbd32def7-b002-4e12-89ad-b7d13754d82a2
205023salicylic acid 30 MG/ML Medicated ShampooSCDbd32def7-b002-4e12-89ad-b7d13754d82a2
205023salicylic acid 3 % Medicated ShampooSYbd32def7-b002-4e12-89ad-b7d13754d82a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-443-01513160443011 BOTTLE in 1 CARTON (51316-443-01) / 133 mL in 1 BOTTLE1 bottle2024-08-28NoNoCurrent