FDA.reportPublic FDA data

Infants Gas Relief

Product NDC
17856-5894
Requested package NDC
17856-5894-4
11-digit product format
178565894
Labeler code
17856
Product ID
17856-5894_02bce983-fd0b-4992-8889-9d988bdb7133
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-12-07
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
20 mg/.3mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17856-589417856-5894-4IInactivated by FDA2026-10-15

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 · 17 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
17856-5894-12023-01-30MAJOR INFANT GAS RELIEF
17856-5894-22023-01-30MAJOR INFANT GAS RELIEF
17856-5894-32023-01-30MAJOR INFANT GAS RELIEF
17856-5894-42023-01-30MAJOR INFANT GAS RELIEF
17856-5894-62023-01-30MAJOR INFANT GAS RELIEF
17856-5894-72023-01-30MAJOR INFANT GAS RELIEF
17856-5894-12021-06-30MAJOR INFANT GAS RELIEF
17856-5894-32021-06-30MAJOR INFANT GAS RELIEF
17856-5894-42021-06-30MAJOR INFANT GAS RELIEF
17856-5894-72021-06-30MAJOR INFANT GAS RELIEF
17856-5894-12020-01-31MAJOR INFANT GAS RELIEF
17856-5894-32020-01-31MAJOR INFANT GAS RELIEF
17856-5894-42020-01-31MAJOR INFANT GAS RELIEF
17856-5894-72020-01-31MAJOR INFANT GAS RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-5894-1Infants Gas Relief10 mL in 1 CUPSUSPENSION/ DROPS107
17856-5894-2Infants Gas Relief120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1207
17856-5894-2Infants Gas Relief0.6 mL in 1 SYRINGESUSPENSION/ DROPS0.67
17856-5894-3Infants Gas Relief.3 mL in 1 SYRINGESUSPENSION/ DROPS.37
17856-5894-4Infants Gas Relief60 in 1 CASESUSPENSION/ DROPS607
17856-5894-4Infants Gas Relief1.2 mL in 1 DOSE PACKSUSPENSION/ DROPS1.27
17856-5894-6Infants Gas Relief120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1207
17856-5894-6Infants Gas Relief0.6 mL in 1 SYRINGESUSPENSION/ DROPS0.67
17856-5894-7Infants Gas Relief120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1207
17856-5894-7Infants Gas Relief.3 mL in 1 SYRINGESUSPENSION/ DROPS.37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-5894INFANTS GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS [ATLANTIC BIOLOGICALS CORPS]7Legacy NDC, 10 package rows20210701_fa869550-a0a8-4359-8d23-d2d178090549.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSNfa869550-a0a8-4359-8d23-d2d1780905497
198857simethicone 66.7 MG/ML Oral SuspensionSCDfa869550-a0a8-4359-8d23-d2d1780905497
198857simethicone 20 MG per 0.3 ML Oral SuspensionSYfa869550-a0a8-4359-8d23-d2d1780905497
198857simethicone 40 MG per 0.6 ML Oral SuspensionSYfa869550-a0a8-4359-8d23-d2d1780905497

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-5894-41785658940460 DOSE PACK in 1 CASE (17856-5894-4) > 1.2 mL in 1 DOSE PACK60 dose pack2021-06-300000-00-00NoNoCurrent