Infants Gas Relief Drops

Product NDC
49035-709
11-digit product format
490350709
Labeler code
49035
Product ID
49035-709_42223d4a-ac52-c3c5-e063-6394a90a3723
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
EMULSION
Route
ORAL
Labeler
Wal-Mart Stores,Inc.,
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-16
Substance
DIMETHICONE, UNSPECIFIED
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

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Infants Gas Relief Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED20 mg/.3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198857Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
966f0506-c2d2-4d3c-bd2d-c5a6b1e0a157Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-709-01Infants Gas Relief Drops1 in 1 CARTONEMULSION112
49035-709-01Infants Gas Relief Drops30 mL in 1 BOTTLEEMULSION3012
49035-709-30Infants Gas Relief Drops30 mL in 1 BOTTLEEMULSION3012
49035-709-30Infants Gas Relief Drops1 in 1 CARTONEMULSION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-709-30ML - Milliliter49035-709ac900725-9928-443a-b64d-14e2b7d42dbf12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-709INFANTS GAS RELIEF DROPS (SIMETHICONE) EMULSION [WAL-MART STORES,INC.,]11Current NDC, Legacy NDC, 4 package rows20241116_966f0506-c2d2-4d3c-bd2d-c5a6b1e0a157.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 4 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Gas Relief CherrySIMETHICONEGood Sense (Geiss, Destin & Dunn, Inc.)91f72cf2-297d-48db-8f05-f8a7050d92e82026-03-31WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEHyvee Inc44ea37b1-8cd2-936d-e063-6394a90a2be72026-03-27WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEGrocery Outlet, Inc.44672e28-3305-a8cc-e063-6394a90a5fef2026-03-23WarningsExact identifier
application number: M002
gas reliefSIMETHICONEBIONPHARMA INC.4d7a9507-6f3c-6d15-e063-6294a90a01602026-03-20WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ea6e04dd-4f57-4a88-b269-af38732915b32026-03-19WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.4d658287-358f-d358-e063-6294a90a4bd32026-03-19WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.410d80fc-e55b-08d0-e063-6294a90aba732026-03-18WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEWalgreensafcabb34-4ef4-4938-860f-154c204fcd482026-03-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC2c7bac92-4596-40aa-a2f2-4ebe380f1f2f2026-03-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC51dc6493-2f9f-4148-be7d-abfef1b251122026-03-10WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONETOP CARE (Topco Associates LLC)ed8a723a-7dac-4670-8f02-f4154e0a36c92026-03-02WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corpfafb57da-0682-475e-8ff9-17f2182129ef2026-02-24WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 180 MGPioneer Life Sciences, LLCf5284b68-f167-41d4-8b2f-ae7bafae0f4c2026-02-13WarningsExact identifier
application number: M002
SFEIXE ANTIFUNGAL PENUNDECYLENIC ACIDZhejiang JOOZENA Medical Technology Co., Ltd.455ad304-86bc-0abe-e063-6294a90a5b432026-02-12WarningsExact identifier
application number: M002
Gas Relief Ultimate Strength SoftgelsSIMETHICONEAdvanced Rx LLC5d412711-efd3-4b27-bfde-6fee2f460f8b2026-02-01WarningsExact identifier
application number: M002
Pepto Gas plus BloatingSIMETHICONEThe Procter & Gamble Manufacturing Company76fa24d0-731e-4fde-9ad6-c4c890b816b42026-01-20WarningsExact identifier
application number: M002
QUITA COLICOS Gas RELIEF DropsSIMETHICONEDLC Laboratories, Inc.d4b0fa36-5925-4a6f-b3c9-0c785503976f2026-01-07WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONESafeway, Inc.7ecfe412-6a58-4dff-a52e-2e02a03426f92026-01-05WarningsExact identifier
application number: M002
Simethicone 180 MGSIMETHICONE 180 MGFarmacias De Similares TX LLC4b2166f7-8d98-dd76-e063-6394a90a7f0f2026-01-01WarningsExact identifier
application number: M002
Target Gas Relief Chews Mixed Berry and StrawberrySIMETHICONETarget11fd2ccd-3a2b-c141-e063-6394a90ab34f2025-12-20WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN966f0506-c2d2-4d3c-bd2d-c5a6b1e0a15712
198857simethicone 66.7 MG/ML Oral SuspensionSCD966f0506-c2d2-4d3c-bd2d-c5a6b1e0a15712
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY966f0506-c2d2-4d3c-bd2d-c5a6b1e0a15712
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY966f0506-c2d2-4d3c-bd2d-c5a6b1e0a15712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-709-01490350709011 BOTTLE in 1 CARTON (49035-709-01) / 30 mL in 1 BOTTLE1 bottle2017-10-160000-00-00NoNoCurrent
49035-709-30490350709301 BOTTLE in 1 CARTON (49035-709-30) / 30 mL in 1 BOTTLE1 bottle2019-10-220000-00-00NoNoCurrent