Calamine Phenolated Topical Suspension

Product NDC
0395-9109
11-digit product format
003959109
Labeler code
0395
Product ID
0395-9109_a8798ec9-22e3-1e0a-e053-2a95a90a4754
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine and Zinc Oxide and Phenol
Dosage form
LOTION
Route
TOPICAL
Labeler
Humco Holding Group, Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2008-01-01
Marketing end
0000-00-00
Substance
ZINC OXIDE; PHENOL
Active strength
160 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0395-9109-962022-07-29C16284748780-1e4f33bdf-a7de-d8a0-e053-dadaa90a6e4ePrivate Label Calamine Phenolated Topical Suspension, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-9109-96Calamine Phenolated Topical Suspension177 mL in 1 BOTTLE, PLASTICLOTION1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9109CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC.]3Legacy NDC, 1 package rows20200620_605258e1-e509-4086-e053-2a91aa0af29f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991369calamine 8 % / phenol 1 % / zinc oxide 8 % Topical LotionPSN605258e1-e509-4086-e053-2a91aa0af29f3
991369calamine 80 MG/ML / phenol 10 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD605258e1-e509-4086-e053-2a91aa0af29f3
991369calamine 8 % / phenol 1 % / zinc oxide 8 % Topical LotionSY605258e1-e509-4086-e053-2a91aa0af29f3
991369calamine 8 % / phenol 1 % / zinc oxide 8 % Topical SuspensionSY605258e1-e509-4086-e053-2a91aa0af29f3
991369Calamine 80 MG/ML / phenol 10 MG/ML / ZNO 80 MG/ML Topical LotionSY605258e1-e509-4086-e053-2a91aa0af29f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-9109-9600395910996177 mL in 1 BOTTLE, PLASTIC (0395-9109-96) 177 ml2017-11-160000-00-00NoNoCurrent