FDA.reportPublic FDA data

Calprotect

Product NDC
69618-067
11-digit product format
696180067
Labeler code
69618
Product ID
69618-067_4b32706a-c97a-589c-e063-6294a90abc11
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Reliable 1 Laboratories LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
Substance
MENTHOL; ZINC OXIDE
Active strength
.44; 20.6 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-067-71Calprotect71 g in 1 JAROINTMENT715
69618-067-82Calprotect113 g in 1 TUBEOINTMENT1135

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-067-71GM - Gram69618-0674d28b714-56c8-4898-a629-9c8e2cde284312023-12-05
69618-067-82GM - Gram69618-0672549dd69-0e5c-435a-aa71-3b84f4ead93512023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-067CALPROTECT (MENTHOL, ZINC OXIDE) OINTMENT [RELIABLE 1 LABORATORIES LLC]4Current NDC, 2 package rows20250121_09fb2810-0cc1-b2e2-e063-6294a90a4576.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2702497CalProtect 0.44 % / zinc oxide 20.6 % Topical OintmentPSN09fb2810-0cc1-b2e2-e063-6294a90a45765
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentPSN09fb2810-0cc1-b2e2-e063-6294a90a45765
2702497menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calprotect]SBD09fb2810-0cc1-b2e2-e063-6294a90a45765
2123045menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCD09fb2810-0cc1-b2e2-e063-6294a90a45765
2702497Calprotect (menthol 0.44 % / zinc oxide 20.6 % ) Topical OintmentSY09fb2810-0cc1-b2e2-e063-6294a90a45765
2123045Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical OintmentSY09fb2810-0cc1-b2e2-e063-6294a90a45765
2702497menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical Ointment [Calprotect]SY09fb2810-0cc1-b2e2-e063-6294a90a45765
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentSY09fb2810-0cc1-b2e2-e063-6294a90a45765

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69618-067-716961800677171 g in 1 JAR (69618-067-71) 71 g2021-01-01NoNoHistorical
69618-067-8269618006782113 g in 1 TUBE (69618-067-82) 113 g2021-01-01NoNoHistorical