FDA.reportPublic FDA data

Savvy

Product NDC
83650-102
11-digit product format
836500102
Labeler code
83650
Product ID
83650-102_299db12c-6fda-1418-e063-6394a90a870a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride Zinc acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Savvy Care and Cosmetics
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-22
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
2; .1 g/100g; g/100g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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
Savvy
Brand name suffix
Itch Stopping
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE2 g/100g
ZINC ACETATE.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup
FM5526K07AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1087026Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
05ee2662-6a51-6e49-e063-6294a90a4ed7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83650-102-01SavvyItch Stopping35.4 g in 1 TUBECREAM35.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83650-102SAVVY ITCH STOPPING (DIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATE) CREAM [SAVVY CARE AND COSMETICS]2Current NDC, 1 package rows20241222_05ee2662-6a51-6e49-e063-6294a90a4ed7.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 20 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diaper RashZINC OXIDETarget Corporation8059f489-f144-4de5-9454-ac6c1af35dd22026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Coconut Milk and Shea Petroleum JellyWHITE PETROLATUMTarget Corporationc78d9864-92e0-4ad8-8a9b-9752ac6784e82026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC043375b2-e636-4822-9e05-df2327d299862026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae2026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMValu Merchandisers Company4113bb6e-070a-4116-a8d6-12c6b4475beb2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEValu Merchandisers Companye5465ddd-e38c-44a4-bb9b-3edbc636576d2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMValu Merchandisers Company8b8decec-e921-4ff9-bb49-7e38e34724f62026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEValu Merchandisers Company0cccadd7-11f3-5d1f-e063-6294a90a55c42026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELValu Merchandisers Company7c6fa37f-79b8-4409-b7a9-3f02332f887a2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEUnited Natural Foods, Inc. dba UNFI014d0028-486e-4f1c-a14f-8162e393ebca2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMUnited Natural Foods, Inc. dba UNFI29a3a719-5e8b-407d-b9d9-bdba267582922026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDETopco Associates LLC8acb1b47-70ed-4aa2-a7c0-e807042affc72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMTopco Associates LLC3babe2cf-9e6c-4f22-940f-c1fdf489f1c72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATETopco Associates LLC8d3d1ff5-4868-495d-807c-e45aa2176f632026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
HealingPETROLATUMTopco Associates LLCb929b159-4af5-4a03-8e7c-676a6ba2bf552026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMTopco Associates LLCcd7f1727-0b6e-4993-9820-43783994efa12026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONETopco Associates LLCf37f17f7-f084-4b74-8361-178d2315a4762026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALTopco Associates LLC4f6af42c-f41e-455f-b94b-3793bf0b9a3f2026-02-13Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN05ee2662-6a51-6e49-e063-6294a90a4ed72
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD05ee2662-6a51-6e49-e063-6294a90a4ed72
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY05ee2662-6a51-6e49-e063-6294a90a4ed72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83650-102-018365001020135.4 g in 1 TUBE (83650-102-01) 35.4 g2023-09-22NoNoCurrent