FDA.reportPublic FDA data

infants gas relief drops

Product NDC
62011-0187
11-digit product format
620110187
Labeler code
62011
Product ID
62011-0187_f17b1bb2-3b3b-471c-9496-c4853c2b5257
Type
HUMAN OTC DRUG
Nonproprietary name
simethicone
Dosage form
EMULSION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-10-21
Marketing end
0000-00-00
Substance
DIMETHICONE
Active strength
20 mg/.3mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62011-0187DDiscontinued by firm2026-08-17
excluded packagepackage62011-018762011-0187-1DDiscontinued by firm2026-08-17

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-0187-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0187-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62011-0187-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62011-0187-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62011-0187-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62011-0187-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62011-0187-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62011-0187-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62011-0187-10efc9e666f02…f202fb6c5f17…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0187-1ML - Milliliter62011-0187e411708f-24c7-45c2-9eb3-c4f86667e49f12013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [HEALTH MART]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [HEALTH MART]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [HEALTH MART]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [HEALTH MART]1
SORBITOLINACTIVE INGREDIENT506T60A25RINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [HEALTH MART]1
WATERINACTIVE INGREDIENT059QF0KO0RINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [HEALTH MART]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEINFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [HEALTH MART]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62011-0187-1620110187011 BOTTLE, DROPPER in 1 CARTON (62011-0187-1) > 30 mL in 1 BOTTLE, DROPPER2019-10-210000-00-00NoNoCurrent