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#

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 39 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIGHTS Insect Sting Relief PadBENZOCAINELights Medical Manufacture Co., Ltd.ccb4185c-1a67-4775-9392-16bc0f7df3cc2026-01-21WarningsExact identifier
application number: M017
Equate Pain Relieving Cream LidocaineLIDOCAINEWal-Mart Stores Inc52b91508-22aa-4c4b-94f4-977f14a01dad2026-01-20WarningsExact identifier
application number: M017
Easment advanced absorption creamCAPSAICIN 0.1%Easment LLC48de3ced-f67f-7c86-e063-6294a90a340c2026-01-20WarningsExact identifier
application number: M017
Black Cobra Tattoo NumbingSpray 4% LidocaineLIDOCAINEFoshan Sugar Max Cosmetics CO.,Ltd3605fcbf-63c8-87b5-e063-6294a90a9c3e2026-01-19WarningsExact identifier
application number: M017
Black Cobra Tattoo Numbing Cream 4% LidocaineLIDOCAINEFoshan Sugar Max Cosmetics CO.,Ltd3605961a-d596-9c4a-e063-6394a90a99dc2026-01-19WarningsExact identifier
application number: M017
Bakers Best Arthritis Pain ReliefHISTAMINE DIHYDROCHLORIDEBaker's Best Health Products, LLC869735f9-335e-4a5e-adfc-91167ae943c52026-01-19WarningsExact identifier
application number: M017
SIMPLY VITAL PAIN RELIEF HEMPMENTHOLALPHA PLANTS INCc14f4c06-cfe5-497e-9f9e-b2ba442e61bb2026-01-19WarningsExact identifier
application number: M017
AsperFlexMENTHOL AND METHYL SALICYLATEAkron Pharma Inc.117de175-976d-44f3-85ed-3d127fbe3a7c2026-01-19WarningsExact identifier
application number: M017
Equate Pain Relieving Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATEWal-Mart Stores Inc5ed1d7b3-925e-4a18-8e15-636f5b442ad72026-01-19WarningsExact identifier
application number: M017
Equate Medicated Pain Relieving Patch, Large 6-CountCAMPHOR, MENTHOL, METHYL SALICYLATEWalmart Stores Inc2c25cd7a-7e7b-5add-e063-6294a90a9e9b2026-01-19WarningsExact identifier
application number: M017
Equate Hydrocortione1% HYDROCORTISONEWalmart Inc.85b7f620-cc95-4333-b124-bbcc8fd5f7eb2026-01-19WarningsExact identifier
application number: M017
GuruNanda Pain ReliefMENTHOLGURUNANDA, LLC3f1d146e-0d18-7f2f-e063-6394a90ab8162026-01-19WarningsExact identifier
application number: M017
Aspercreme with LidocaineLIDOCAINEChattem, Inc.7ad8efa9-7031-4cd0-be1d-6dee63091fd12026-01-19WarningsExact identifier
application number: M017
Best Choice Targeted Warming Capsaicin Heat PatchCAPSAICINValu Merchandisers Company24ca40b7-e17b-42a3-bcc8-6861b9a5934a2026-01-18WarningsExact identifier
application number: M017
TOPCARE PAIN RELIEF PATCHESLIDOCAINETOPCO ASSOCIATES, LLCfa2f7768-e779-4409-aad3-6c33ce2e6b362026-01-18WarningsExact identifier
application number: M017
Neuropathy Pain Relief CreamMENTHOL CREAMOwell Naturals Brand, LLC48979093-2992-5fd8-e063-6394a90a815d2026-01-17WarningsExact identifier
application number: M017
CVS Lidocaine Pain Relief CreamLIDOCAINE HYDROCHLORIDECVS Pharmacy45c4f946-13b9-7a0a-e063-6394a90a73532026-01-16WarningsExact identifier
application number: M017
TopCare Pain Relieving CreamLIDOCAINE HCL 4%Topco Associates, LLC4885a7e6-a127-450a-e063-6294a90a4f912026-01-16WarningsExact identifier
application number: M017
CalmaraCALMARADynarex Corporation487393e9-6619-6033-e063-6294a90a68b22026-01-16WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONE OINTMENTWalgreens7088092c-3a5f-4fcc-84cc-931d238f75012026-01-15WarningsExact 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