FDA.reportPublic FDA data

Happy Cappy

Product NDC
71566-100
11-digit product format
715660100
Labeler code
71566
Product ID
71566-100_b3c53131-dc78-4198-80f6-50d840f1badd
Type
HUMAN OTC DRUG
Nonproprietary name
pyrithione zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Pediatric Solutions, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-07
Substance
PYRITHIONE ZINC
Active strength
.0095 g/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71566-100-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71566-100-08f5e01cc5f278…a2eaf40c39c3…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71566-100-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71566-100-11ad56d346431e…cc804d4bbf1e…

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
Happy Cappy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC.0095 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R953O2RHZ5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091088Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d3828d8-ee15-4aff-99d1-a121f0102a00Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71566-100-08Happy Cappy237 mL in 1 BOTTLE, PLASTICSHAMPOO2379

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71566-100HAPPY CAPPY (PYRITHIONE ZINC) SHAMPOO [PEDIATRIC SOLUTIONS, LLC]8Current NDC, Legacy NDC, 1 package rows20241222_3d3828d8-ee15-4aff-99d1-a121f0102a00.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 56 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Daily MoisturizingDIMETHICONEKenvue Brands LLC70593b0c-c41b-4294-9bfa-42003ba1e3e42024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC029fbae2-06ad-4fe9-b542-834686c5cb972024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief OvernightDIMETHICONEKenvue Brands LLCe7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c2024-11-05WarningsExact identifier
application number: M016
Quality Choice Diaper RashZINC OXIDEChain Drug Marketing Association Inc.262e7eac-4b44-f224-e063-6394a90a4f592024-11-05WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDEChain Drug Marketing Association Inc.262f8cab-c7b8-b07e-e063-6294a90a12892024-11-05WarningsExact identifier
application number: M016
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY926706b5-0a08-4604-b5ad-3b3ddfd7f02d2024-11-05WarningsExact identifier
application number: M016
Walgreens Eczema Relief Body Skin ProtectantOATMEALWalgreen Companyb2eebc2f-addd-4822-b224-04bd5f4506532024-11-05WarningsExact identifier
application number: M016
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY81eb3df4-5beb-45aa-82ca-e8b4b37e45f42024-11-05Warnings, Adverse reactionsExact identifier
application number: M016
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC567b1481-b783-45f9-af38-5630c9edf0442024-11-01WarningsExact identifier
application number: M016
ZO Skin Health Astringent SolutionALUMINUM ACETATEZO Skin Health, Inc.cb801d7e-52ad-6c16-e053-2a95a90a7a1f2024-10-31WarningsExact identifier
application number: M016
ZINC OXIDE PHARMAZINC OXIDEALLIED TRADE LINK LLC1b580bf6-f217-5c0f-e063-6294a90a012e2024-10-29WarningsExact identifier
application number: M016
Dove DermaSeries Eczema Relief Soothing BodyCOLLOIDAL OATMEALConopco, Inc. d/b/a/ Unilever59f737f6-dd3f-4b63-b13e-2345cb9a951a2024-10-24WarningsExact identifier
application number: M016
DoveHAND SANITIZER SHEA BUTTERConopco Inc. d/b/a/ Unilevera735d885-bacd-0f5c-e053-2a95a90ad14a2024-10-24WarningsExact identifier
application number: M016
Baby Dove8H MOISTURIZATION HAND SANITIZERConopco Inc. d/b/a/ Unileverb8dc481c-1ac3-2d63-e053-2a95a90a44f52024-10-24WarningsExact identifier
application number: M016
VaselineCLINICAL CARE HAND SANITIZER LOTIONConopco Inc. d/b/a/ Unileverba0aa323-8887-597f-e053-2995a90a20772024-10-24WarningsExact identifier
application number: M016
DoveNOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATIONConopco Inc. d/b/a/ Unileverd1039316-3ca8-90f8-e053-2995a90a20612024-10-24WarningsExact identifier
application number: M016
DoveHAND SANITIZER LAVENDERConopco Inc. d/b/a/ Unilevera736838b-b559-f066-e053-2995a90a90f52024-10-24WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDERejoice International Corp.130d94d8-ad98-d61f-e063-6294a90a76b02024-10-21WarningsExact identifier
application number: M016
HARMON DAILY MOISTURZIERDIMETHICONEHARMON STORES, INC.bda5dbaa-5d62-4a40-ba55-e2066e8ca1c72024-10-21WarningsExact identifier
application number: M016
DimethiconeBODY SHIELDMcKesson8febb45d-a200-702c-e053-2995a90a3e622024-10-18WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091088zinc pyrithione 0.95 % Medicated ShampooPSN3d3828d8-ee15-4aff-99d1-a121f0102a009
1091088zinc pyrithione 9.5 MG/ML Medicated ShampooSCD3d3828d8-ee15-4aff-99d1-a121f0102a009
1091088zinc pyrithione 0.95 % Medicated ShampooSY3d3828d8-ee15-4aff-99d1-a121f0102a009

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71566-100-0871566010008237 mL in 1 BOTTLE, PLASTIC (71566-100-08) 237 ml2017-12-070000-00-00NoNoCurrent
71566-100-117156601001115 mL in 1 PACKET (71566-100-11) 15 ml2019-09-290000-00-00NoNoCurrent