Vitale Sensitive Scalp Daily Scalp Healer

Product NDC
49681-001
11-digit product format
496810001
Labeler code
49681
Product ID
49681-001_a09678e5-709e-4af9-a4e2-b4c2c00f2621
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
CREAM
Route
TOPICAL
Labeler
New Life Products, Inc.
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-11-01
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
250 mg/100g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49681-001IInactivated by FDA2026-09-14
excluded packagepackage49681-00149681-001-01IInactivated by FDA2026-09-14

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49681-001-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49681-001-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49681-001-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49681-001-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49681-001-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49681-001-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49681-001-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49681-001-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49681-001-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49681-001-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49681-001-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49681-001-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49681-001-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49681-001-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49681-001-011332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage49681-001-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage49681-001-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage49681-001-01110d247fa046…a55b01930146…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49681-001-01Vitale Sensitive Scalp Daily Scalp Healer114 g in 1 JARCREAM1142

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Pyrithione ZincACTIVE INGREDIENTR953O2RHZ5VITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Pyrithione ZincACTIVE MOIETYR953O2RHZ5VITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
1,3-dimethylol-5,5-dimethyl-hydantoinINACTIVE INGREDIENTBYR0546TOWVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Alpha-tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L0VITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
BiotinINACTIVE INGREDIENT6SO6U10H04VITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
CamphorINACTIVE INGREDIENT5TJD82A1ETVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1SVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1OVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Equisetum Arvense ExtractINACTIVE INGREDIENT1L0VKZ185EVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Eucalyptus OilINACTIVE INGREDIENT2R04ONI662VITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
MentholINACTIVE INGREDIENTL7T10EIP3AVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Mineral OilINACTIVE INGREDIENTT5L8T28FGPVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Olive OilINACTIVE INGREDIENT6UYK2W1W1EVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3VITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Sodium BorateINACTIVE INGREDIENT91MBZ8H3QOVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Stearalkonium ChlorideINACTIVE INGREDIENT0OUO26BB88VITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Vitamin A PalmitateINACTIVE INGREDIENT1D1K0N0VVCVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1
Wax, YellowINACTIVE INGREDIENT2ZA36H0S2VVITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49681-001VITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [NEW LIFE PRODUCTS, INC.]2Legacy NDC, 1 package rows20210128_9aeada50-2cb2-d113-126a-ddcf05f817b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259549zinc pyrithione 0.25 % Topical CreamPSN9aeada50-2cb2-d113-126a-ddcf05f817b62
259549zinc pyrithione 2.5 MG/ML Topical CreamSCD9aeada50-2cb2-d113-126a-ddcf05f817b62
259549zinc pyrithione 0.25 % Topical CreamSY9aeada50-2cb2-d113-126a-ddcf05f817b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49681-001-0149681000101114 g in 1 JAR (49681-001-01) 114 g2009-11-010000-00-00NoNoCurrent