FDA.reportPublic FDA data

Extra Strength

Product NDC
52000-071
11-digit product format
520000071
Labeler code
52000
Product ID
52000-071_1853be3d-62de-dc6b-e063-6394a90aad99
Type
HUMAN OTC DRUG
Nonproprietary name
Itch Stopping Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Universal Distribution Centre LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-21
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
20; 1 mg/g; mg/g
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
2027-12-31
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
Extra Strength
Brand name suffix
Itch Stopping
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE20 mg/g
ZINC ACETATE1 mg/g

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
b9a42aa3-1903-76f0-e053-2a95a90a51d1Available 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
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
52000-071-03Extra StrengthItch Stopping35.4 g in 1 TUBECREAM35.43
52000-071-04Extra StrengthItch Stopping1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-071EXTRA STRENGTH ITCH STOPPING (ITCH STOPPING CREAM) CREAM [UNIVERSAL DISTRIBUTION CENTRE LLC]3Current NDC, Legacy NDC, 2 package rows20240515_b9a42aa3-1903-76f0-e053-2a95a90a51d1.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 56 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY81eb3df4-5beb-45aa-82ca-e8b4b37e45f42024-11-05Warnings, Adverse reactionsExact identifier
application number: M016
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC567b1481-b783-45f9-af38-5630c9edf0442024-11-01WarningsExact identifier
application number: M016
ZO Skin Health Astringent SolutionALUMINUM ACETATEZO Skin Health, Inc.cb801d7e-52ad-6c16-e053-2a95a90a7a1f2024-10-31WarningsExact identifier
application number: M016
ZINC OXIDE PHARMAZINC OXIDEALLIED TRADE LINK LLC1b580bf6-f217-5c0f-e063-6294a90a012e2024-10-29WarningsExact identifier
application number: M016
Dove DermaSeries Eczema Relief Soothing BodyCOLLOIDAL OATMEALConopco, Inc. d/b/a/ Unilever59f737f6-dd3f-4b63-b13e-2345cb9a951a2024-10-24WarningsExact identifier
application number: M016
DoveHAND SANITIZER SHEA BUTTERConopco Inc. d/b/a/ Unilevera735d885-bacd-0f5c-e053-2a95a90ad14a2024-10-24WarningsExact identifier
application number: M016
Baby Dove8H MOISTURIZATION HAND SANITIZERConopco Inc. d/b/a/ Unileverb8dc481c-1ac3-2d63-e053-2a95a90a44f52024-10-24WarningsExact identifier
application number: M016
VaselineCLINICAL CARE HAND SANITIZER LOTIONConopco Inc. d/b/a/ Unileverba0aa323-8887-597f-e053-2995a90a20772024-10-24WarningsExact identifier
application number: M016
DoveNOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATIONConopco Inc. d/b/a/ Unileverd1039316-3ca8-90f8-e053-2995a90a20612024-10-24WarningsExact identifier
application number: M016
DoveHAND SANITIZER LAVENDERConopco Inc. d/b/a/ Unilevera736838b-b559-f066-e053-2995a90a90f52024-10-24WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDERejoice International Corp.130d94d8-ad98-d61f-e063-6294a90a76b02024-10-21WarningsExact identifier
application number: M016
HARMON DAILY MOISTURZIERDIMETHICONEHARMON STORES, INC.bda5dbaa-5d62-4a40-ba55-e2066e8ca1c72024-10-21WarningsExact identifier
application number: M016
DimethiconeBODY SHIELDMcKesson8febb45d-a200-702c-e053-2995a90a3e622024-10-18WarningsExact identifier
application number: M016
PETROLEUMWHITE PETROLATUMVIVE HEALTH LLC24ae3875-1c86-c7ba-e063-6394a90a67292024-10-17WarningsExact identifier
application number: M016
Meijer Skin Relieving MoisturizingDIMETHICONEMEIJER DISTRIBUTION, INC8e5be6b3-87e7-d958-e053-2a95a90a69612024-10-16WarningsExact identifier
application number: M016
GenRx Daily Defense Skin RepairingDIMETHICONEPureTek Corporation7d2827fd-b40f-454b-bb60-54d77823b18c2024-10-16WarningsExact identifier
application number: M016
Equate Daily Moisturizing Dimethicone Skin ProtectantDIMETHICONEWalmart Stores Inc.8fda01f7-a52a-4a63-98ac-b32cb47947f32024-10-16WarningsExact identifier
application number: M016
Hill Country EssentialsDIMETHICONEH.E.Bc51d8647-8af6-473a-b989-dfa6bfdc368d2024-10-15WarningsExact identifier
application number: M016
UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTEDWHITE PETROLEUMUniversal Distribution Center LLC649e571f-0cd6-41e4-b31f-c818f94fb01d2024-10-15WarningsExact identifier
application number: M016
WALGREENS ECZEMACOLLOIDAL OATMEALWALGREEN COMPANYfc502963-4cb6-5ce5-e053-6394a90a58c32024-10-14WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSNb9a42aa3-1903-76f0-e053-2a95a90a51d13
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDb9a42aa3-1903-76f0-e053-2a95a90a51d13
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSYb9a42aa3-1903-76f0-e053-2a95a90a51d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-071-02520000071021 TUBE in 1 CARTON (52000-071-02) > 35.4 g in 1 TUBE (52000-071-01) 1 tube2021-01-210000-00-00NoNoCurrent
52000-071-035200000710335.4 g in 1 TUBE35.4 gHistorical
52000-071-04520000071041 TUBE in 1 CARTON (52000-071-04) / 35.4 g in 1 TUBE (52000-071-03) 1 tube2021-01-21NoNoCurrent