Home NDC 53943-400 DDM Calaclear
Product NDC 53943-400
11-digit product format 539430400
Labeler code 53943
Product ID 53943-400_0ce5be01-e0bc-7245-e063-6294a90acccf
Type HUMAN OTC DRUG
Nonproprietary name Zinc Acetate and Pramoxine Hydrochloride
Dosage form LOTION
Route TOPICAL
Labeler Discount Drug Mart
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 1998-03-25
Substance ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength 80; 10 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 DDM Calaclear
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 80 mg/mL PRAMOXINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 88AYB867L5 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53943-400-96 DDM Calaclear 177 mL in 1 BOTTLE, PLASTIC LOTION 177 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53943-400 DDM CALACLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [DISCOUNT DRUG MART] 4 Current NDC, Legacy NDC, 1 package rows 20231220_5d536077-b5c6-29b8-e053-2a91aa0a9ae1.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 61 of 68 · 1,343 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Chapstick Moisturizer Cool Mint AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM Haleon US Holdings LLC 33497c07-ad6e-4c50-bc23-a55725b2eae1 2024-03-21 Warnings Exact identifier application number: M016 Chapstick Moisturizer Original AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM Haleon US Holdings LLC de250ae9-6e4a-46ca-bcc9-5bb07dbb70c5 2024-03-21 Warnings Exact identifier application number: M016 ChapStick Classic Strawberry WHITE PETROLATUM Haleon US Holdings LLC 3a279496-74c5-4ab1-ba69-06ad4a4f67cf 2024-03-21 Warnings Exact identifier application number: M016 Chapstick Moisturizer Cool Mint AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM Haleon US Holdings LLC c1120c7a-1fa8-45a4-8bcf-35d9cc9f2c74 2024-03-21 Warnings Exact identifier application number: M016 terrasil Diabetics Ulcer and Sore Relief Kit ALLANTOIN Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 523b6598-8039-4116-b0f8-ba31d7d6ea9d 2024-03-20 Warnings Exact identifier application number: M016 ChapStick Classic Cherry WHITE PETROLATUM Haleon US Holdings LLC db041b1b-084a-4283-b6ba-4d4bcdc220b3 2024-03-19 Warnings Exact identifier application number: M016 ChapStick Classic Original WHITE PETROLATUM Haleon US Holdings LLC 42fe0f4a-efb7-4e70-a359-db7dc2ac9905 2024-03-19 Warnings Exact identifier application number: M016 ChapStick Classic Spearmint WHITE PETROLATUM Haleon US Holdings LLC 74354d8e-c265-4a27-9715-1a4c157ad890 2024-03-19 Warnings Exact identifier application number: M016 Cetaphil Healing PETROLATUM Galderma Laboratories, L.P. e996db17-bd4d-4b06-bb9a-983dbdec8022 2024-03-13 Warnings Exact identifier application number: M016 Diaper Rash Cream 2oz ZINC OXIDE Rejoice International Corp. 130a06a7-3360-afed-e063-6294a90ac19f 2024-03-06 Warnings Exact identifier application number: M016 mama bear DIAPER RASH Skin Protectant LANOLIN AND PETROLATUM AMAZON.COM SERVICES LLC cda9ca47-b668-4a65-908d-80b9a6515bd7 2024-03-06 Warnings Exact identifier application number: M016 Dermachange Scar ALLANTOIN Private Label Beauty and Wellness 12eed473-10d6-49c8-e063-6394a90afb63 2024-03-05 Warnings Exact identifier application number: M016 XtraCare Creamy Petroleum Jelly Cocoa Butter Enriched PETROLEUM Rejoice International 580d76ee-ea89-426e-bd25-7a58481e9795 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Creamy Petroleum Jelly Vitamin E enriched PETROLATUM Rejoice International 2c382a50-93d2-4d28-b7a4-1702b20b7139 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Foaming Facial Cleanser TRICLOSAN Rejoice International 313fcd4a-8641-417e-bf0b-02359ad815fe 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Skin Relief Oatmeal Daily Moisturizing DIMETHICONE Rejoice International 5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907 2024-02-28 Warnings Exact identifier application number: M016 XtraCare with cooling action Oatmeal Skin Relief Calmin DIMETHICONE Rejoice International 29abd476-c32d-49f0-b283-30f4ba570ab4 2024-02-28 Warnings Exact identifier application number: M016 MAX BARRIER Skin Protectant ZINC OXIDE GL HEALTH, INC. 5eec834d-d8f3-49e3-b230-f8cf88b795e6 2024-02-26 Warnings Exact identifier application number: M016 Rugby Petrolatum Hydrating Skin Protectant PETROLATUM Rugby Laboratories ad63e345-1fe8-4f9a-a32e-8dfcde31bedc 2024-02-12 Warnings Exact identifier application number: M016 A and D PETROLATUM Safetec of America, Inc. b9afda3a-9e1d-46c1-b7aa-c3143caf709e 2024-02-09 Warnings Exact identifier application number: M016
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53943-400-96 53943040096 177 mL in 1 BOTTLE, PLASTIC (53943-400-96) 177 ml 2017-10-26 0000-00-00 No No Current