Home NDC 0713-0623-32 Carlesta
Product NDC 0713-0623
Requested package NDC 0713-0623-32
11-digit product format 007130623
Labeler code 0713
Product ID 0713-0623_9b268d07-4090-4e8f-8604-3f9243b0ddfe
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone, Zinc Oxide
Dosage form OINTMENT
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 1999-09-08
Marketing end 0000-00-00
Substance DIMETHICONE; ZINC OXIDE
Active strength 20 mg/g; mg/g
NDC exclude flag No
Listing certified through 2020-12-31
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 · 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dimethicone ACTIVE INGREDIENT 92RU3N3Y1O CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Zinc Oxide ACTIVE INGREDIENT SOI2LOH54Z CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Dimethicone ACTIVE MOIETY 92RU3N3Y1O CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Zinc Oxide ACTIVE MOIETY SOI2LOH54Z CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Butylated Hydroxytoluene INACTIVE INGREDIENT 1P9D0Z171K CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Cod Liver Oil INACTIVE INGREDIENT BBL281NWFG CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Lanolin INACTIVE INGREDIENT 7EV65EAW6H CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Light Mineral Oil INACTIVE INGREDIENT N6K5787QVP CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Polysorbate 40 INACTIVE INGREDIENT STI11B5A2X CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Tea Tree Oil INACTIVE INGREDIENT VIF565UC2G CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0713-0623-32 00713062332 56.8 g in 1 TUBE (0713-0623-32) 56.8 g 1999-09-08 0000-00-00 No No Current