FDA.reportPublic FDA data

Industrial Itch and Pain Relief

Product NDC
59555-002
11-digit product format
595550002
Labeler code
59555
Product ID
59555-002_834e7e81-dbe6-40e9-a053-47a4b4423602
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE and Zinc Acetate
Dosage form
LIQUID
Route
TOPICAL
Labeler
R & R Lotion, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
20; 1 mg/mL; mg/mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Industrial Itch and Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, FM5526K07A
Rxcui1294589

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59555-002-182025-09-11C16284748780-12cef2736-b052-d83d-e063-dadaa90ab31fIndustrial Itch and Pain Relief
59555-002-192025-09-11C16284748780-12cef2736-b052-d83d-e063-dadaa90ab31fIndustrial Itch and Pain Relief
59555-002-182025-01-30C16284748780-12cef2736-b052-d83d-e063-dadaa90ab31fIndustrial Itch and Pain Relief
59555-002-192025-01-30C16284748780-12cef2736-b052-d83d-e063-dadaa90ab31fIndustrial Itch and Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59555-002-18Industrial Itch and Pain Relief1 mL in 1 PACKETLIQUID13
59555-002-19Industrial Itch and Pain Relief20 mL in 1 BOTTLE, WITH APPLICATORLIQUID203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59555-002INDUSTRIAL ITCH AND PAIN RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) LIQUID [R & R LOTION, INC]2Current NDC, Legacy NDC, 2 package rows20210115_236415fc-f923-4a82-b54a-ecaf666dd2e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1294589diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SolutionPSN236415fc-f923-4a82-b54a-ecaf666dd2e03
1294589diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SolutionSCD236415fc-f923-4a82-b54a-ecaf666dd2e03
1294589diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SolutionSY236415fc-f923-4a82-b54a-ecaf666dd2e03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59555-002-18595550002181 mL in 1 PACKET (59555-002-18) 1 ml2019-05-010000-00-00NoNoCurrent
59555-002-195955500021920 mL in 1 BOTTLE, WITH APPLICATOR (59555-002-19) 20 ml2019-05-010000-00-00NoNoCurrent