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 61 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Classic SpearmintPETROLATUMHaleon US Holdings LLCd39786e8-bcd8-479d-8990-142a21788a472024-04-12WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLCd6eb2ea6-27c7-40a6-a1f0-789ea2131de32024-04-11WarningsExact identifier
application number: M016
Chapstick Active 2in1 Variety PackZINC OXIDEHaleon US Holdings LLCd1998a9e-d61f-4b4c-91b0-5e66754bcc4a2024-04-11WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLC040694f0-b5ba-4203-bde9-699fa9b1afef2024-04-11WarningsExact identifier
application number: M016
Chapstick Holiday Classics KitWHITE PETROLATUMHaleon US Holdings LLC6df216dc-c03d-463a-8029-5e54c1dc3d272024-04-11WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated SPF15 Triple Force FormulaOCTINOXATE, OXYBENZONE, WHITE PETROLATUMCarma Laboratories, Inc.3eb0f8ff-89e7-4410-8573-3349e49465482024-04-02WarningsExact identifier
application number: M016
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
application number: M016
ChapStick Supreme Classic CherryWHITE PETROLATUMHaleon US Holdings LLC84d8cc38-83e3-49be-b180-d01820525b602024-03-22WarningsExact identifier
application number: M016
Chapstick Moisturizer OriginalAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC9cd13fbb-887f-46a8-9f0b-4450ad3e07b72024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Peachy KeenZINC OXIDEHaleon US Holdings LLCef206fe7-2659-41dc-b117-380af704999b2024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Pretty in PinkZINC OXIDEHaleon US Holdings LLCe686ce23-57bc-4026-be62-d46d90ded4422024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Very BerryZINC OXIDEHaleon US Holdings LLC59023150-65ef-4427-9045-0e64b100cbab2024-03-22WarningsExact identifier
application number: M016
Chapstick Moisturizer Cool MintAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLC33497c07-ad6e-4c50-bc23-a55725b2eae12024-03-21WarningsExact identifier
application number: M016
Chapstick Moisturizer OriginalAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCde250ae9-6e4a-46ca-bcc9-5bb07dbb70c52024-03-21WarningsExact identifier
application number: M016
ChapStick Classic StrawberryWHITE PETROLATUMHaleon US Holdings LLC3a279496-74c5-4ab1-ba69-06ad4a4f67cf2024-03-21WarningsExact identifier
application number: M016
Chapstick Moisturizer Cool MintAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLCc1120c7a-1fa8-45a4-8bcf-35d9cc9f2c742024-03-21WarningsExact identifier
application number: M016
terrasil Diabetics Ulcer and Sore Relief KitALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions523b6598-8039-4116-b0f8-ba31d7d6ea9d2024-03-20WarningsExact identifier
application number: M016
ChapStick Classic CherryWHITE PETROLATUMHaleon US Holdings LLCdb041b1b-084a-4283-b6ba-4d4bcdc220b32024-03-19WarningsExact identifier
application number: M016
ChapStick Classic OriginalWHITE PETROLATUMHaleon US Holdings LLC42fe0f4a-efb7-4e70-a359-db7dc2ac99052024-03-19WarningsExact identifier
application number: M016
ChapStick Classic SpearmintWHITE PETROLATUMHaleon US Holdings LLC74354d8e-c265-4a27-9715-1a4c157ad8902024-03-19WarningsExact 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