Home NDC 17856-1303-2 Infants
Product NDC 17856-1303
Requested package NDC 17856-1303-2
11-digit product format 178561303
Labeler code 17856
Product ID 17856-1303_3288018d-5d72-4792-e063-6294a90a2c8c
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form SUSPENSION/ DROPS
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-09-01
Substance DIMETHICONE
Active strength 20 mg/.3mL
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 13 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 2025-04-01 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base Infants
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 20 mg/.3mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198857 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 17856-1303-1 Infants 120 in 1 BOX, UNIT-DOSE SUSPENSION/ DROPS 120 2 17856-1303-1 Infants 0.3 mL in 1 SYRINGE SUSPENSION/ DROPS 0.3 2 17856-1303-2 Infants 0.3 mL in 1 SYRINGE SUSPENSION/ DROPS 0.3 2 17856-1303-2 Infants 120 in 1 BOX, UNIT-DOSE SUSPENSION/ DROPS 120 2 17856-1303-3 Infants 0.6 mL in 1 SYRINGE SUSPENSION/ DROPS 0.6 2 17856-1303-3 Infants 120 in 1 BOX, UNIT-DOSE SUSPENSION/ DROPS 120 2 17856-1303-4 Infants 120 in 1 BOX, UNIT-DOSE SUSPENSION/ DROPS 120 2 17856-1303-4 Infants 0.6 mL in 1 SYRINGE SUSPENSION/ DROPS 0.6 2 17856-1303-5 Infants 1.2 mL in 1 SYRINGE SUSPENSION/ DROPS 1.2 2 17856-1303-5 Infants 60 in 1 BOX, UNIT-DOSE SUSPENSION/ DROPS 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-1303 INFANTS (SIMETHICONE) SUSPENSION/ DROPS [ATLANTIC BIOLOGICALS CORP.] 2 Current NDC, Legacy NDC, 10 package rows 20250426_27fce442-e328-41d2-bab9-87ab21550c04.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 1 of 13 · 258 matching rows.
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 17856-1303-2 17856130302 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1303-2) / .3 mL in 1 SYRINGE 120 syringe 2021-06-30 0000-00-00 No No Current