Home NDC 69612-016-01 PSP Calamine
Product NDC 69612-016
Requested package NDC 69612-016-01
11-digit product format 696120016
Labeler code 69612
Product ID 69612-016_df73c9a6-1582-0287-e053-2995a90a562e
Type HUMAN OTC DRUG
Nonproprietary name ZINC CARBONATE, ZINC OXIDE
Dosage form SUSPENSION
Route TOPICAL
Labeler RW Consumer Products Ltd
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2021-10-01
Marketing end 2022-05-27
Substance ZINC CARBONATE; ZINC OXIDE
Active strength 76 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69612-016-01 69612001601 1 BOTTLE, PLASTIC in 1 BOX (69612-016-01) > 250 mL in 1 BOTTLE, PLASTIC 2021-10-01 0000-00-00 No No Current