FDA.reportPublic FDA data

Itch Relief Cream

Product NDC
68016-163
11-digit product format
680160163
Labeler code
68016
Product ID
68016-163_29b74830-5473-c90b-e063-6294a90a4e72
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Acetate 0.1%, Diphenhydramine hydrochloride 2%
Dosage form
CREAM
Route
TOPICAL
Labeler
Pharmacy Value Alliance LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-19
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
Itch Relief Cream
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
37fe6d82-adee-4f58-e054-00144ff88e88Available 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-05-09Itch Relief Cream
2023-01-30Itch Relief Cream
2021-08-10Itch Relief Cream
2021-01-29Itch Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-163-01Itch Relief Cream28 g in 1 TUBECREAM288
68016-163-01Itch Relief Cream1 in 1 BOXCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-163ITCH RELIEF CREAM (ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%) CREAM [PHARMACY VALUE ALLIANCE LLC]8Current NDC, Legacy NDC, 2 package rows20241222_37fe6d82-adee-4f58-e054-00144ff88e88.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 59 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POMG NIGHT TIME PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDEPOMG LLC28d7dfb0-a94c-90de-e063-6294a90a036a2025-12-02WarningsExact identifier
application number: M017
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
application number: M017
SUNSET COOLING PAIN RELIEF ROLL-ONMENTHOLSUNSET NOVELTIES, INC45037bc1-aa03-11ae-e063-6294a90a6c962025-12-02WarningsExact identifier
application number: M017
SUNSET HEATING PAIN RELIEF ROLL-ONCAMPHORSUNSET NOVELTIES, INC45048936-f3c9-25f7-e063-6394a90ac4a92025-12-02WarningsExact identifier
application number: M017
CAREALL Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAMNew World Imports, Inc3a01f57a-ebc6-4724-b625-1d1ea4b85e732025-12-01WarningsExact identifier
application number: M017
CareALL Arthritis and MuscleCAPSAICINNew World Imports, Inc4867eac4-00ea-434e-b289-1c1ef0342c232025-12-01WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Ince2df8130-e7c8-4fde-a6d6-c713789912132025-12-01WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incd04e473d-8bbc-475c-a0b1-ca5eed67fbc72025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Inccba7c084-379f-4a16-aeba-b11ca6e20d8a2025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Incd066002d-8ceb-4d16-9744-d5ca25d2ad5a2025-12-01WarningsExact identifier
application number: M017
CAREALL Musle and JointMENTHOLNew World Imports, Inc013beea4-b2c2-4e84-b4cb-3125ac48e8c02025-12-01WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINA2A Integrated Pharmaceuticals, LLC147f3594-7362-7a78-e063-6294a90a3e422025-11-30WarningsExact identifier
application number: M017
Aquanil HCHYDROCORTISONEPerson and Covey6b9258e4-c7c4-765e-e053-2991aa0a9f4e2025-11-29WarningsExact identifier
application number: M017
Walgreen Pain Relieving Fragrance FreeLIDOCAINE HYDROCHLORIDEWALGREENS CO.62c50ded-3fc9-4f65-9bfb-1144ed2e36b42025-11-26WarningsExact identifier
application number: M017
Itch ReliefITCH RELIEF GELNeilmed Pharmaceuticals Inc.44811828-c32e-17fc-e063-6294a90add482025-11-26WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
application number: M017
Sohm Pain AwayMENTHOL, CAMPHORSOHM, Inc86632acf-80ae-48d7-a0bb-7ec980326bae2025-11-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Pain ReliefLIDOCAINE 4%Veridian Healthcare6f2332c0-e078-40a8-9564-f47d21bc491b2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC44779065-5f57-8f01-e063-6394a90a3f8e2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC44786cb6-176e-cc6e-e063-6394a90a54ad2025-11-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN37fe6d82-adee-4f58-e054-00144ff88e888
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD37fe6d82-adee-4f58-e054-00144ff88e888
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY37fe6d82-adee-4f58-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-163-01680160163011 TUBE in 1 BOX (68016-163-01) / 28 g in 1 TUBE1 tube2016-09-010000-00-00NoNoCurrent