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 41 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Infection Protection Wound CareALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse98d1d8c-c979-49de-9bd8-cd409efff6de2025-07-11WarningsExact identifier
application number: M016
Neosporin Lip Health Overnight Renewal TherapyPETROLATUMKenvue Brands LLC0da54fe1-c99f-4a2d-9ee5-2dc24005096c2025-07-10WarningsExact identifier
application number: M016
COCOA BUTTER PETROLEUM jellyPETROLATUMSavvy Care & Cosmetics Pvt. Ltd.397d13f1-3b86-3c76-e063-6394a90a0f242025-07-09WarningsExact identifier
application number: M016
Pipette EczemaCOLLOIDAL OATMEALPipette LLC39829827-d801-f5a7-e063-6394a90a024c2025-07-09WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEWestminster Pharmaceuticals, LLC7e045b3a-f33b-4faa-ab9b-2baec6ff79242025-07-08WarningsExact identifier
application number: M016
Desitin Multi-Purpose HealingPETROLATUMKenvue Brands LLC30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab2025-07-07WarningsExact identifier
application number: M016
Astringent SolutionALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATEFirst Nation Group065c895c-7d86-f1ed-e063-6394a90a3a522025-07-07WarningsExact identifier
application number: M016
Creamy PetroleumPETROLATUMSavvy Care & Cosmetics Pvt Ltd3916daee-f8d2-e3f0-e063-6294a90a38832025-07-04WarningsExact identifier
application number: M016
Exemax CreamDIMETHICONE, ALLANTOINPureTek Corporation38e79055-df84-d314-e063-6394a90ac95f2025-07-01WarningsExact identifier
application number: M016
Procure Dimethicone 5%DIMETHICONETwin Med LLC38a7e4af-997d-549e-e063-6394a90a0bd62025-06-28WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDerma Sciences Canada Inc.37eff762-1ea9-ec66-e063-6394a90a3d102025-06-19WarningsExact identifier
application number: M016
Dr.Johnes SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLCb731c55e-31ee-429f-8432-fac7c5718d832025-06-18WarningsExact identifier
application number: M016
Dr. Johne SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLC6c5adc3c-9d45-449a-ad42-f9571851cd182025-06-18WarningsExact identifier
application number: M016
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal OatmealOATMEALTHERAPLEX, LLCe51aa467-ffe7-4c6b-8588-6df8592596d42025-06-16WarningsExact identifier
application number: M016
ZIIDII Wild Yam CreamWILD YAMGuangzhou Haishi Biological Technology Co., Ltd.3733154a-4884-9988-e063-6294a90aa78c2025-06-10WarningsExact identifier
application number: M016
Aveeno Calm Plus Restore Skin Therapy BalmCOLLOIDAL OATMEALKenvue Brands LLCdbe7a2cc-9c21-2a48-e053-2a95a90a54e22025-06-04WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWALGREENS2017113f-d192-5fbb-e063-6294a90a83b02025-05-31WarningsExact identifier
application number: M016
AHHH Bite ReliefSODIUM BICARBONATE7827125a1e070-9228-4ec9-e063-6294a90ad78d2025-05-27WarningsExact identifier
application number: M016
SupreH Bee Venom Skin Tag Treatment LiquidSUPREH BEE VENOM SKIN TAG REMOVER LIQUIDShenzhen Xinxin Yunhai Technology Co., Ltd.35ca9836-917a-b0ac-e063-6294a90a28a22025-05-23WarningsExact identifier
application number: M016
terrasil Diabetics Ulcer and Bed Sore ReliefALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions35d2738c-dacf-7309-e063-6294a90aab4c2025-05-23WarningsExact 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