FDA.reportPublic FDA data

Itch Relief

Product NDC
61010-8300
11-digit product format
610108300
Labeler code
61010
Product ID
61010-8300_109674e0-ef83-5844-e063-6394a90ae6b8
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-02
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
20.3 g/L
Pharmacologic classes
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
Itch Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE20.3 g/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1050080Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f4c801b-d894-4fa3-b024-6ca41a5f2a95Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-8300-12024-02-13C16284748780-11030e365-2119-111a-e063-dadaa90a10e261010-8300, Itch Relief Spray
61010-8300-12024-01-30C16284748780-11030e365-2119-111a-e063-dadaa90a10e261010-8300, Itch Relief Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-8300-1Itch Relief0.0591 L in 1 BOTTLE, SPRAYLIQUID0.05913

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1
diphenhydramineACTIVE MOIETY8GTS82S83MITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1
C12-15 PARETH-9INACTIVE INGREDIENTH3ZIY6WP1RITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW4ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1
trolamineINACTIVE INGREDIENT9O3K93S3TKITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-8300ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]3Current NDC, Legacy NDC, 1 package rows20240214_4f4c801b-d894-4fa3-b024-6ca41a5f2a95.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 65 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hempvana Cold As Ice Pain ReliefMENTHOLTelebrands Corp95e84bb9-ba2e-5009-e053-2995a90a43622025-11-12WarningsExact identifier
application number: M017
LidozallLIDOCAINE HYDROCHLORIDEV2 Pharma LLC1eb2dfb2-3ad1-488b-aed9-17220e34a10c2025-11-12WarningsExact identifier
application number: M017
Lidozall PlusLIDOCAINE HYDROCHLORIDEV2 Pharma LLCba3cbb15-f4ed-443e-af43-a758481acb0b2025-11-12WarningsExact identifier
application number: M017
Knee Pain Relief PatchDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATEShenzhen Finona Information Technology Co., Ltd38755738-1a06-fdb4-e063-6294a90aa6eb2025-11-12WarningsExact identifier
application number: M017
Recovery NumbLIDOCAINE 4%PURKLENZ FORMULATIONS INC.e95e38e3-f743-4f5c-abdf-99ba6856e6f72025-11-12WarningsExact identifier
application number: M017
Rapid ReliefCOLD RELIEF PATCH 5% MENTHOLRAPID AID VIET NAM COMPANY LIMITED434c13c2-52ee-000f-e063-6294a90af7e72025-11-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MGRAPID AID VIET NAM COMPANY LIMITED434d5f92-05c2-d884-e063-6394a90ad28c2025-11-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED434df0be-49ff-aa56-e063-6394a90a3b5a2025-11-11WarningsExact identifier
application number: M017
TopCare Pain Relief Maximum StrengthLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATESb0ae3a7c-52d1-4923-bd50-6bb3749006c82025-11-11WarningsExact identifier
application number: M017
ComfortcaineLIDOCAINE HCLQS Key West Aloe, LLC831b7c11-e437-4e74-808e-c9c1eb8b82f62025-11-11WarningsExact identifier
application number: M017
A and E Marathon Delay SerumDELAY SERUMPhe Inc4355d1d8-44fe-aca1-e063-6294a90a85ff2025-11-11WarningsExact identifier
application number: M017
A and E Deep Throat Desensitizing SprayStrawberryORAL NUMBING SPRAY STRAWBERRYPhe Inc4355dab1-a293-ded6-e063-6394a90af9b02025-11-11WarningsExact identifier
application number: M017
A and E Easy Anal GelANAL NUMBING LUBRICANTPhe Inc4355e0f3-65ba-eca6-e063-6394a90ab43c2025-11-11WarningsExact identifier
application number: M017
A and E Deep Throat Desensitizing SprayPeppermintORAL NUMBING SPRAY MINTPhe Inc4355e0d0-1222-d594-e063-6294a90abb292025-11-11WarningsExact identifier
application number: M017
DermaNumb AnalgesicLIDOCAINE HCLA.T.S. Laboratories, LLC0ea46890-45c3-4732-bc47-227f7c67daf12025-11-11WarningsExact identifier
application number: M017
Derma Numb Pain ReliefLIDOCAINE HCLA.T.S. Laboratories, LLC710991ae-8f82-4893-93a7-0ef3f815d1322025-11-11WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEEncube Ethicals, Inc.969cd576-82d3-4662-bbc1-3587a1f6a5642025-11-10WarningsExact identifier
application number: M017
Jelcaine SterileLIDOCAINE HCL JELLY USP, 2%Brookfield Pharmaceuticals, LLC1a39d1de-7aa2-3068-e063-6394a90aed852025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anestheticc6e86a0f-6f9b-45b7-86ce-0bb1c198061a2025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anesthetic97ae1993-7268-4b7f-92e2-6004337d56502025-11-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1050080diphenhydrAMINE HCl 2 % Topical SprayPSN4f4c801b-d894-4fa3-b024-6ca41a5f2a953
1050080diphenhydramine hydrochloride 20 MG/ML Topical SpraySCD4f4c801b-d894-4fa3-b024-6ca41a5f2a953
1050080diphenhydramine HCl 2 % Topical SpraySY4f4c801b-d894-4fa3-b024-6ca41a5f2a953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61010-8300-161010830001.0591 L in 1 BOTTLE, SPRAY (61010-8300-1) 2013-05-020000-00-00NoNoCurrent