Home NDC 59970-075 Calamine
Product NDC 59970-075
11-digit product format 599700075
Labeler code 59970
Product ID 59970-075_31cda82e-11b2-4537-9f32-f54b01141bb8
Type HUMAN OTC DRUG
Nonproprietary name zinc oxide, ferric oxide red, pramozine HCl
Dosage form LOTION
Route TOPICAL
Labeler Navarro Discount Pharmacies, LLC
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-06-03
Marketing end 0000-00-00
Substance ZINC OXIDE; FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
Active strength 80 mg/mL; mg/mL; mg/mL
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 · 44 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 59970-075-01 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 59970-075-01 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 59970-075-01 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 59970-075-01 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 59970-075-01 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 59970-075-01 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 59970-075-01 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 59970-075-01 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 59970-075-01 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 59970-075-01 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 59970-075-01 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 59970-075-01 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 59970-075-01 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 59970-075-01 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 59970-075-01 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 59970-075-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 59970-075-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 59970-075-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 59970-075-01 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 59970-075-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 59970-075-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…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 59970-075-01 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.
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 59970-075-01 Calamine 177 mL in 1 BOTTLE LOTION 177 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FERRIC OXIDE RED ACTIVE INGREDIENT 1K09F3G675 CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 PRAMOXINE HYDROCHLORIDE ACTIVE INGREDIENT 88AYB867L5 CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 FERRIC OXIDE RED ACTIVE MOIETY 1K09F3G675 CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 PRAMOXINE ACTIVE MOIETY 068X84E056 CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 CAMPHOR (NATURAL) INACTIVE INGREDIENT N20HL7Q941 CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59970-075 CALAMINE (ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL) LOTION [NAVARRO DISCOUNT PHARMACIES, LLC] 1 Legacy NDC, 1 package rows 20130603_7f2c5adf-92ca-4257-b71b-f7578a481c92.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 59970-075-01 59970007501 177 mL in 1 BOTTLE 177 ml Historical