Rugby Caldyphen Clear

Product NDC
0536-1269
11-digit product format
005361269
Labeler code
0536
Product ID
0536-1269_3afc5367-562d-b4a0-e063-6294a90a2560
Type
HUMAN OTC DRUG
Nonproprietary name
pramoxine hydrochloride and zinc acetate lotion
Dosage form
LOTION
Route
TOPICAL
Labeler
Rugby Laboratories
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-30
Marketing end
2027-09-30
Substance
PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength
10; 1 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rugby Caldyphen Clear

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL
ZINC ACETATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5, FM5526K07A
Rxcui1234546

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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1269-58Rugby Caldyphen Clear177 mL in 1 CONTAINERLOTION1775

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1269-58ML - Milliliter0536-1269c3254484-090a-4240-9387-013b7e8bd07112020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1269RUGBY CALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION) LOTION [RUGBY LABORATORIES]4Current NDC, Legacy NDC, 1 package rows20231215_9af3a740-ef97-26ce-e053-2a95a90a0ee1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSN9af3a740-ef97-26ce-e053-2a95a90a0ee15
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCD9af3a740-ef97-26ce-e053-2a95a90a0ee15
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSY9af3a740-ef97-26ce-e053-2a95a90a0ee15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1269-5800536126958177 mL in 1 CONTAINER (0536-1269-58) 177 ml2019-12-302027-09-30NoNoCurrent