FDA.reportPublic FDA data

signature care itch relief

Product NDC
21130-154
11-digit product format
211300154
Labeler code
21130
Product ID
21130-154_4e0a1cc6-292f-46d7-a5a1-0b8b642ca8fd
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride, Zinc Acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Safeway
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-09-01
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
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
signature care itch relief
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
3eedcd9f-8312-4d14-a0fe-6b00a00d3e73Available 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
21130-154-64signature care itch relief1 in 1 CARTONCREAM13
21130-154-64signature care itch relief28 g in 1 TUBECREAM283

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SIGNATURE CARE ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [SAFEWAY]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07ASIGNATURE CARE ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [SAFEWAY]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSIGNATURE CARE ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [SAFEWAY]1
ZINC CATIONACTIVE MOIETY13S1S8SF37SIGNATURE CARE ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [SAFEWAY]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSIGNATURE CARE ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [SAFEWAY]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4SIGNATURE CARE ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [SAFEWAY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSIGNATURE CARE ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [SAFEWAY]1
PEG-2 STEARATEINACTIVE INGREDIENT94YQ11Y95FSIGNATURE CARE ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [SAFEWAY]1
PEG-20 STEARATEINACTIVE INGREDIENTNBX892EA57SIGNATURE CARE ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [SAFEWAY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SIGNATURE CARE ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [SAFEWAY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSIGNATURE CARE ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [SAFEWAY]1
WATERINACTIVE INGREDIENT059QF0KO0RSIGNATURE CARE ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-154SIGNATURE CARE ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [SAFEWAY]3Current NDC, Legacy NDC, 2 package rows20241015_3eedcd9f-8312-4d14-a0fe-6b00a00d3e73.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 96 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Pain ReliefMENTHOL 10.5%CVSd0ea80ce-38b2-acde-e053-2995a90a47e52025-03-31WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEA2A Integrated Pharmaceuticals, LLC31431866-6fb5-2acd-e063-6294a90ac5202025-03-31WarningsExact identifier
application number: M017
Citrus Cleansing Foot Soak and Body SoakCAMPHORSANSAR, LLCf136616d-9f32-4e55-a495-b7466fd685262025-03-28WarningsExact identifier
application number: M017
Zpol ULTRAMENTHOL, METHYL SALICYLATELaboratorios Zepol S.A.1a1433a6-8d04-96df-e063-6394a90a987b2025-03-27WarningsExact identifier
application number: M017
Muscle Recovery Foot Soak and Body SoakCAMPHORSANSAR, LLC1c347267-b653-41bf-9967-7feff17c38af2025-03-27WarningsExact identifier
application number: M017
Soothing Lavender Foot Soak and Body SoakCAMPHORSANSAR, LLCef26523a-b2f2-466e-89ad-f293cd64decb2025-03-27WarningsExact identifier
application number: M017
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc31408e21-e58d-6db5-e063-6294a90aa4bc2025-03-26WarningsExact identifier
application number: M017
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc3143bb72-2969-d66e-e063-6294a90a46042025-03-26WarningsExact identifier
application number: M017
Parche LeonCAPSAICIN, CAMPHOR, MENTHOLPharmadel LLCa8f266fa-6e43-559e-e053-2995a90a2c752025-03-26WarningsExact identifier
application number: M017
Adellina Numbing CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.314a83fe-8bdb-766f-e063-6294a90a61c62025-03-26WarningsExact identifier
application number: M017
HealthWise Lidocaine Plus Menthol PatchLIDOCAINE AND MENTHOLVeridian Healthcare312f15fe-9297-2dc2-e063-6294a90a6f4d2025-03-25WarningsExact identifier
application number: M017
HealthWise Lidocaine PatchLIDOCAINE 4%Veridian Healthcare3130729d-1679-90cd-e063-6294a90a21e62025-03-25WarningsExact identifier
application number: M017
HealthWise Lidocaine PatchLIDOCAINE 4%Veridian Healthcare31314dda-6199-574d-e063-6394a90aae7a2025-03-25WarningsExact identifier
application number: M017
RWSEFK Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.31366793-f8a6-a2c4-e063-6294a90acbfc2025-03-25WarningsExact identifier
application number: M017
Forticept Wounds and Burns HydrogelBENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDELidan, inc.c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f2025-03-25WarningsExact identifier
application number: M017
MQ Pain Relieving PatchPAIN RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0978ff22-c357-e266-e063-6394a90a98a42025-03-24WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHAdvanced Rx of Tennessee, LLC30c97646-db06-df84-e063-6394a90a77432025-03-20WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e572025-03-20WarningsExact identifier
application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPFCAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECarma Laboratories, Inc.5f904369-5f21-4907-98de-df23bce308232025-03-20WarningsExact identifier
application number: M017
DermaCort Anti-itchHYDROCORTISONEMelaleuca, Inc.24044b0f-dd1e-4762-82b8-7a28b08c2f772025-03-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN3eedcd9f-8312-4d14-a0fe-6b00a00d3e733
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD3eedcd9f-8312-4d14-a0fe-6b00a00d3e733
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY3eedcd9f-8312-4d14-a0fe-6b00a00d3e733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-154-64211300154641 TUBE in 1 CARTON (21130-154-64) / 28 g in 1 TUBE1 tube2015-09-010000-00-00NoNoCurrent