Home NDC 70000-0397 Calamine Clear
Product NDC 70000-0397
11-digit product format 700000397
Labeler code 70000
Product ID 70000-0397_185584d0-0662-431c-e063-6394a90a4827
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine Hydrochloride and Zinc Acetate Lotion
Dosage form LOTION
Route TOPICAL
Labeler Cardinal Health, 110 dba Leader
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-01-15
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
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 70000-0397 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 70000-0397 70000-0397-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 Calamine Clear
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 10 mg/mL ZINC ACETATE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88AYB867L5 Internal UNII lookup FM5526K07A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234546 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0397-1 Calamine Clear 177 mL in 1 BOTTLE, PLASTIC LOTION 177 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0397 CALAMINE CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION) LOTION [CARDINAL HEALTH, 110 DBA LEADER] 5 Current NDC, Legacy NDC, 1 package rows 20240514_7f733c0a-82b2-d3b0-e053-2991aa0a6b0f.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 27 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eucerin Eczema Relief Body OATMEAL Beiersdorf Inc 9895f3c3-b00b-462c-ace0-696d688e2e04 2025-12-31 Warnings Exact identifier application number: M016 Eucerin Eczema Relief Flare Up Treatment OATMEAL Beiersdorf Inc a9ea4832-3211-40b2-accf-90ace7b9e279 2025-12-31 Warnings Exact identifier application number: M016 Eczema Relief Cream Body Wash OATMEAL Beiersdorf Inc f12644e5-0ff0-de0e-e053-2995a90a0995 2025-12-31 Warnings Exact identifier application number: M016 XIMONTH Honey Eye Drops GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 4727f304-0bc7-2fee-e063-6394a90a0178 2025-12-30 Warnings Exact identifier application number: M016 Kinfield Relief Balm Anti-Itch Remedy KINFIELD RELIEF BALM ANTI-ITCH REMEDY Kinfield, Inc. bf394192-c789-faff-e053-2995a90a52bc 2025-12-30 Warnings Exact identifier application number: M016 911 ALLANTOIN Skinfix, Inc. f28c251e-a91b-4ed4-8224-b47c345f982f 2025-12-29 Warnings Exact identifier application number: M016 EXTRA STRENGTH BODY COLLOIDAL OATMEAL Skinfix, Inc. 32ba5f29-c037-44dd-b5b1-59001ac50753 2025-12-29 Warnings Exact identifier application number: M016 VITACILINA Bebe Diaper Rash ALLANTOIN, ZINC OXIDE Compania Internacional de Comercio, S.A.P.I de C.V. 39726b59-bd85-4541-80e5-4f2919842dca 2025-12-29 Warnings Exact identifier application number: M016 Creamy Diaper Rash ZINC OXIDE Davion, Inc 0fdfe7d3-e4cd-6bea-e063-6394a90a37f6 2025-12-29 Warnings Exact identifier application number: M016 Medicated Cornstarch Baby Powder ACTIVE CORN STARCH Davion, Inc. e39032d1-c8cd-4a41-af10-126970b8ad38 2025-12-29 Warnings Exact identifier application number: M016 WinCo FoodsPetroleum Jelly WHITE PETROLATUM WinCo Foods, LLC f5dcf0b2-4f9f-023a-e053-2995a90a183a 2025-12-28 Warnings Exact identifier application number: M016 WinCo FoodsPetroleum Jelly WHITE PETROLATUM WinCo Foods, LLC f5dca60a-e9bc-4161-e053-2995a90a2bcb 2025-12-28 Warnings Exact identifier application number: M016 Hydrating Healing HYDRATING HEALING OINTMENT Neilmed Pharmaceuticals Inc., 47106abb-4c39-07d9-e063-6394a90a4fae 2025-12-28 Warnings Exact identifier application number: M016 TCX Skincare COLLOIDAL OATMEAL Theraceutix, LLC c3be950b-28cf-47c2-9570-ebd46e43b1ba 2025-12-24 Warnings Exact identifier application number: M016 Nizoral Eczema Relief Cream COLLOIDAL OATMEAL Kramer Laboratories da3a39d7-197f-4451-9d24-f92adbe0fc19 2025-12-23 Warnings Exact identifier application number: M016 Healing Head to Toe ALLANTOIN The Honest Company, Inc dc02033f-8116-1710-e053-2995a90aff69 2025-12-23 Warnings Exact identifier application number: M016 Honest Eczema Cream COLLOIDAL OATMEAL The Honest Company, Inc. 6f111094-425b-4a8c-b71a-5ff65f4a8000 2025-12-23 Warnings Exact identifier application number: M016 BABY ANTI MONKEY BUTT DIAPER RASH ZINC OXIDE, CALAMINE Clarion Brands, LLC e4424d74-f89c-5943-42e8-bf3a38e68619 2025-12-23 Warnings Exact identifier application number: M016 Dissolvable Microneedle Eye Patches ALLANTOIN Advaccine Biopharmaceuticals Suzhou Co., Ltd 4684fa4e-5c5e-045d-e063-6394a90af069 2025-12-22 Warnings Exact identifier application number: M016 Good Neighbor Petroleum Jelly WHITE PETROLATUM AmerisourceBergen e5fb80a0-cc8c-e9e7-e053-2a95a90a455d 2025-12-22 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70000-0397-1 70000039701 177 mL in 1 BOTTLE, PLASTIC (70000-0397-1) 177 ml 2019-01-15 0000-00-00 No No Current