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 6 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas ReliefSIMETHICONEMeijer Distribution, Inc.7723821e-b2fc-4c9c-a389-05184aaea19f2025-11-15WarningsExact identifier
application number: M002
TopCare Extra Strength Gas Relief Cherry CremeSIMETHICONETOPCO ASSOCIATES LLC4d1701fd-b797-4e95-9004-84d528941e722025-11-10WarningsExact identifier
application number: M002
up and up extra strength gas relief chewables Extra StrengthSIMETHICONETarget Corporation0a015c48-680c-4de1-91e7-1c1145239d8e2025-11-04WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONESAFEWAYc8946bd2-6351-40e4-a139-d8214889bb4e2025-10-29WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONE ANTIGASSAFEWAYcbbd43eb-1155-4e0d-bed4-32343f34b5032025-10-29WarningsExact identifier
application number: M002
meijer EXTRA STRENGTH Gas ReliefSIMETHICONEMeijer, Inc3e83bb0f-d909-08c3-e063-6294a90ae1382025-10-29WarningsExact identifier
application number: M002
PUBLIX Extra StrengthSIMETHICONEPUBLIX SUPER MARKETS, INC089d77c9-7aa0-4eee-8363-c47a2d5928cf2025-10-28WarningsExact identifier
application number: M002
Extra Strength gas reliefSIMETHICONEPUBLIX SUPER MARKETS, INC,029f9254-8cfd-4ea0-8691-2d87df4504332025-10-28WarningsExact identifier
application number: M002
Publix Infants Dye Free Gas ReliefSIMETHICONEPUBLIX SUPER MARKETS, INC2fe74800-a1f6-4774-9976-d6767ba34b492025-10-28WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEWal-Mart Stores,Inc.,e6087f04-20bf-402c-892b-e64f778b01442025-10-27WarningsExact identifier
application number: M002
Infants Gas Relief DropsSIMETHICONEWal-Mart Stores,Inc.,966f0506-c2d2-4d3c-bd2d-c5a6b1e0a1572025-10-27WarningsExact identifier
application number: M002
ndc (product): 49035-709
InfantsSIMETHICONERUGBY LABORATORIESc6fa71bc-de48-47f4-80c4-7d92643d26642025-10-25WarningsExact identifier
application number: M002
PHAZYMESIMETHICONEC.B. Fleet Company, Inc.ea04f5a5-cf56-4176-a234-5a73e01ff2182025-10-23WarningsExact identifier
application number: M002
Cardinal Health Infants Gas ReliefSIMETHICONECARDINAL HEALTHe0dec270-dabb-4289-b5e0-bf37f9ddcbcd2025-10-14WarningsExact identifier
application number: M002
Quality Choice Infants Gas Relief Dye FreeSIMETHICONEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)841b85ef-2ac8-4dac-8659-cffb7e1b1e052025-08-23WarningsExact identifier
application number: M002
CVS Health Gas Relief SOFTGELSIMETHICONECVS Pharmacy, Inc2911cac8-45ec-1294-e063-6294a90a4a742025-08-22WarningsExact identifier
application number: M002
TopCare health EXTRA STRENGTH Gas Relief SOFTGELSIMETHICONETopco Associates LLC2ea0eb22-f679-d136-e063-6294a90a1dfe2025-08-01WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAARNA USA Inc.9b0fde90-35ae-498e-99cc-d120f1a871822025-07-29WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONERugby Laboratories, Inc.24731f4b-ca2b-483f-beed-dfc8104f81332025-07-18WarningsExact identifier
application number: M002
Aluminum Hydroxide, Magnesium Hydroxide, and DimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEAmerican Health Packaging23539e7e-a723-460f-892f-dac5bbbb9b162025-07-15WarningsExact 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