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 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

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