Home NDC 43128-035 Pro Advantage Fast Absorbing Perineal with Dimethicone Skin Protectant
Product NDC 43128-035
11-digit product format 431280035
Labeler code 43128
Product ID 43128-035_8152e11f-403b-f83c-e053-2a91aa0a0f4d
Type HUMAN OTC DRUG
Nonproprietary name DIMETHICONE
Dosage form CREAM
Route TOPICAL
Labeler NDC National Distribution & Contracting, Inc.
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-03-07
Marketing end 0000-00-00
Substance DIMETHICONE
Active strength 20 mg/mL
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 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43128-035-02 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43128-035-02 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43128-035-02 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43128-035-02 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43128-035-02 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43128-035-02 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43128-035-02 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43128-035-02 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43128-035-02 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43128-035-02 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43128-035-02 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43128-035-02 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43128-035-02 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43128-035-02 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43128-035-02 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 43128-035-02 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 43128-035-02 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 43128-035-02 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 43128-035-02 8dfbde2a14a4…c9ff85d89658…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43128-035-02 Pro Advantage Fast Absorbing Perineal with Dimethicone Skin Protectant 1 in 1 PACKAGE CREAM 1 4 43128-035-02 Pro Advantage Fast Absorbing Perineal with Dimethicone Skin Protectant 118 mL in 1 TUBE CREAM 118 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43128-035 PRO ADVANTAGE FAST ABSORBING PERINEAL WITH DIMETHICONE SKIN PROTECTANT (DIMETHICONE) CREAM [NDC NATIONAL DISTRIBUTION & CONTRACTING, INC.] 4 Legacy NDC, 2 package rows 20190208_d4f3df9f-94c4-49c5-94cd-4b97ec254993.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43128-035-02 43128003502 1 in 1 PACKAGE Historical