Home NDC 24385-439 Caldyphen Clear
Product NDC 24385-439
11-digit product format 243850439
Labeler code 24385
Product ID 24385-439_52d4acc7-7f67-f62a-e063-6394a90a245d
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine Hydrochloride and Zinc acetate
Dosage form LOTION
Route TOPICAL
Labeler Amerisource Bergen
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-01-01
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 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 · 34 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 24385-439-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 24385-439-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 24385-439-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 24385-439-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 24385-439-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 24385-439-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 24385-439-30 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 24385-439-30 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 24385-439-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 24385-439-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 24385-439-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 24385-439-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 24385-439-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 24385-439-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 24385-439-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 24385-439-30 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 24385-439-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Caldyphen Clear 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 24385-439-30 Caldyphen Clear 177 mL in 1 BOTTLE, PLASTIC LOTION 177 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24385-439 CALDYPHEN CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [AMERISOURCE BERGEN] 3 Current NDC, Legacy NDC, 1 package rows 20200622_d8802e56-649e-4494-86ee-7ca8841cc28b.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 53 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZIMS MAX FREEZE LIDOCAINE HYDROCHLORIDE AND MENTHOL, KOBAYASHI Healthcare International, Inc. e364ff83-4aaf-4897-a7da-06581bc321f2 2025-12-18 Warnings Exact identifier application number: M017 Tiger Balm White Regular Strength CAMPHOR (SYNTHETIC) AND MENTHOL Haw Par Healthcare Ltd. f406161e-a9c4-47d1-8b21-93b1b7938063 2025-12-17 Warnings Exact identifier application number: M017 Resinol PETROLATUM AND RESORCINOL ResiCal, Inc. 03f57a4a-f94b-4ba6-b709-41cfb6e16261 2025-12-17 Warnings Exact identifier application number: M017 HealthWise Maximum Pain Relief LIDOCAINE Veridian Healthcare afc3c16d-0076-44b2-ae7e-5f36d4d8088e 2025-12-17 Warnings Exact identifier application number: M017 HealthWise Max Lidocaine plus Menthol LIDOCAINE, MENTHOL Veridian Healthcare f39a27da-6799-4fc6-97ca-101eac4a9360 2025-12-17 Warnings Exact identifier application number: M017 HealthWise Original Menthol MENTHOL Veridian Healthcare e4bfb6b0-545e-4fbc-8538-4f41a6be1025 2025-12-17 Warnings Exact identifier application number: M017 Welly Polka First Aid Kit HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Dongguan Shenglian Tins Products Co., Ltd. d7c4314c-c4c6-4adf-b384-3ac7a7108319 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Arthritis Pain Therapy MENTHOL Wise Consumer Products 2410a199-f4a3-da6c-e063-6394a90aaace 2025-12-17 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE, MENTHOL Vive Health LLC 462d3b24-643e-91da-e063-6394a90a0e1d 2025-12-17 Warnings Exact identifier application number: M017 Theragesic METHYL SALICYLATE Mission Pharmacal Company db6c0c77-0a20-d574-a98f-e6c9998b941f 2025-12-17 Warnings Exact identifier application number: M017 Teevodar Pain Relieving MENTHOL Sod-e Biotech Ltd 205b0fef-4f00-db2e-e063-6294a90a93b8 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Arthritis Pain Relief MENTHOL WISE CONSUMER PRODUCTS CO. 116045df-891b-f370-e063-6294a90abe42 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Intensive Foot Therapy MENTHOL Wise Consumer Products 23e56c6b-0f2b-721f-e063-6394a90a1ed0 2025-12-17 Warnings Exact identifier application number: M017 Tiger Balm Ultra Strength CAMPHOR (SYNTHETIC) AND MENTHOL Haw Par Healthcare Ltd. f0561804-e0f7-495d-9768-9b86a208c51e 2025-12-17 Warnings Exact identifier application number: M017 Kwan Loong METHYL SALICYLATE AND MENTHOL Haw Par Healthcare Ltd. 54bcb26e-786a-403e-9330-11ae9e3c013a 2025-12-17 Warnings Exact identifier application number: M017 Magsoothium Body Cooling Formula MENTHOL Ubu/Elements, Inc. f7fb6ac9-a920-a440-e053-6394a90aaa35 2025-12-16 Warnings Exact identifier application number: M017 Magsoothium CBD Body Lavender MENTHOL Ubu/Elements, Inc. f9b87fbe-b889-67a1-e053-6394a90acbcd 2025-12-16 Warnings Exact identifier application number: M017 Aquaphor Itch Relief HYDROCORTISONE Beiersdorf Inc b1d0333f-ba60-35d8-e053-2995a90af932 2025-12-16 Warnings Exact identifier application number: M017 Magsoothium CBD Body MENTHOL Ubu/Elements, Inc. 00b2ef34-42d7-523c-e063-6294a90a753d 2025-12-16 Warnings Exact identifier application number: M017 GENTLECARE HAND AND SKIN SANITIZER BENZALKONIUM CHLORIDE PARAGON SOLUTIONS US, INC. 16650277-fa62-485e-9a82-7763d2b50168 2025-12-16 Warnings Exact identifier application number: M017
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 24385-439-30 24385043930 177 mL in 1 BOTTLE, PLASTIC (24385-439-30) 177 ml 2013-06-28 2027-09-30 No No Current