FDA.reportPublic FDA data

Avalon Organics Antidandruff

Product NDC
61995-1606
11-digit product format
619951606
Labeler code
61995
Product ID
61995-1606_39ae13bf-c20b-a955-e063-6294a90a7302
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
The Hain Celestial Group, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-28
Substance
SALICYLIC ACID
Active strength
2 g/414g
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
Avalon Organics Antidandruff
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/414g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
66c7f730-64f3-4eef-e053-2a91aa0a4225Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-07-31Avalon Organic Anti-dandruff Shampoo 153-067C, F01866 Items: AV36106 414g, AV35009 325ml
2024-07-30Avalon Organic Anti-dandruff Shampoo 153-067C, F01866 Items: AV36106 414g, AV35009 325ml
2023-12-06Avalon Organic Anti-dandruff Shampoo 153-067C, F01866 Items: AV36106 414g, AV35009 325ml
2023-01-30Avalon Organic Anti-dandruff Shampoo 153-067C, F01866 Items: AV36106 414g, AV35009 325ml
2021-02-28Avalon Organic Anti-dandruff Shampoo 153-067C, F01866 Items: AV36106 414g, AV35009 325ml
2021-01-29Avalon Organic Anti-dandruff Shampoo 153-067C, F01866 Items: AV36106 414g, AV35009 325ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-1606-8Avalon Organics Antidandruff414 g in 1 BOTTLESHAMPOO41411
61995-1606-9Avalon Organics Antidandruff325 g in 1 BOTTLESHAMPOO32511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-1606AVALON ORGANICS ANTIDANDRUFF (SALICYLIC ACID) SHAMPOO [THE HAIN CELESTIAL GROUP, INC.]10Current NDC, Legacy NDC, 2 package rows20240802_66c7f730-64f3-4eef-e053-2a91aa0a4225.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 48 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TANZINC OXIDEBentley Laboratories, LLC7920708a-6fa7-4bc8-94ba-096e77d9d7e12024-12-27WarningsExact identifier
application number: M016
AD Medicated RashAD MEDICATED RASHWellSpring Pharmaceutical Corporationaac345bf-ea66-4f5b-a497-c24ea72f93ea2024-12-27WarningsExact identifier
application number: M016
ZO Skin Health Post Procedure Recovery SystemALUMINUM ACETATEZO Skin Health, Inc.3b977415-2bf4-43a9-bb48-1eb023ca4f532024-12-27WarningsExact identifier
application number: M016
terrasil Scar RecoveryALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2f91ff-a447-9d2a-e063-6394a90a84f82024-12-26WarningsExact identifier
application number: M016
WITCH HAZELWITCH HAZELCHAIN DRUG MARKETING ASSOCIATION INCbdccee3f-0ad8-4264-a65f-ae86aed6bf032024-12-26WarningsExact identifier
application number: M016
All Over Lavender RosemaryCOLLOIDAL OAT OINTMENTTubby Todd29f46671-7467-95c9-e063-6294a90a13542024-12-23WarningsExact identifier
application number: M016
Sweet Cheeks Diaper SprayerZINC OXIDE DIAPER PASTE SPRAYTubby Todd29f4aa3c-d10e-52a5-e063-6294a90acc4b2024-12-23WarningsExact identifier
application number: M016
calamineCALAMINE AND ZINC OXIDEWALGREEN COMPANYfed3026b-3473-26fe-e053-6294a90a8aa22024-12-23WarningsExact identifier
application number: M016
CUREFINIPETROLATUM, COD LIVER OILMiramar Cosmetics, Inc DBA Miramar Labfc9211db-71aa-44d8-a00b-65f1482d39812024-12-23WarningsExact identifier
application number: M016
CUREFINIPETROLATUMMiramar Cosmetics, Inc DBA Miramar Lab6a2610ca-ca80-451f-8fed-b982443a10b92024-12-23WarningsExact identifier
application number: M016
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC453dffec-de9d-0eac-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC455a16fd-9ce5-6bef-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMTrifecta Pharmaceuticals USA LLCf1eb0ec2-98e7-13a2-e053-2a95a90a29382024-12-20WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDEPharmacy Value Alliance, LLC38018e3f-3778-01d1-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
DiaperRashOintmentZINC OXIDEPharmacy Value Alliance, LLC3aace6d8-d24c-00e1-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
Medicated Body PowderMENTHOLNew Pride Corpf0f0e332-cb93-42a7-e053-2995a90ac4ae2024-12-19WarningsExact identifier
application number: M016
Health Smart Medicated BodyMENTHOL AND ZINC OXIDEInternational Wholesale Inc dba Home Smart Products044870e2-ebac-a095-e063-6294a90a27512024-12-19WarningsExact identifier
application number: M016
White Rain Original PetroleumWHITE PETROLEUMINTERNATIONAL WHOLESALE INC.d6ebe00c-b692-5171-e053-2a95a90a976c2024-12-19WarningsExact identifier
application number: M016
Health Smart Original PetroleumWHITE PETROLEUMHome Smart Productsaedf746f-4c49-421d-a666-1ba02e8fb17d2024-12-19WarningsExact identifier
application number: M016
white rain Cocoa Butter Petroleum JellyWHITE PETROLATUMINTERNATIONAL WHOLESALE INC.d7068e2b-c3b2-d16d-e053-2a95a90a6dd22024-12-19WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61995-1606-861995160608414 g in 1 BOTTLE (61995-1606-8) 414 g2016-07-280000-00-00NoNoCurrent
61995-1606-961995160609325 g in 1 BOTTLE (61995-1606-9) 325 g2025-07-02NoNoCurrent