FDA.reportPublic FDA data

INFANTS GAS RELIEF DROPS

Product NDC
69618-059
11-digit product format
696180059
Labeler code
69618
Product ID
69618-059_0994a4fb-0731-0f98-e063-6394a90a8a58
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
RELIABLE 1 LABORATORIES
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
INFANTS GAS RELIEF DROPS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE20 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b479bf22-3469-7916-e053-2995a90addc8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-059-51INFANTS GAS RELIEF DROPS1 in 1 CARTONSUSPENSION/ DROPS13
69618-059-51INFANTS GAS RELIEF DROPS30 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-059INFANTS GAS RELIEF DROPS (SIMETHICONE) SUSPENSION/ DROPS [RELIABLE 1 LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20231108_b479bf22-3469-7916-e053-2995a90addc8.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 · 258 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
InfantsSIMETHICONERUGBY LABORATORIESc6fa71bc-de48-47f4-80c4-7d92643d26642025-10-25WarningsExact identifier
application number: M002
Meijer Extra Strength Gas ReliefSIMETHICONEMEIJER DISTRIBUTION INC1e8dc937-ad86-4560-bcc1-3f23fbfe8c642025-10-24WarningsExact identifier
application number: M002
Meijer Infants Gas Relief DropsSIMETHICONEMEIJER DISTRIBUTION INC.4493efcd-a547-4700-9e6a-a67d6420edb52025-10-24WarningsExact identifier
application number: M002
PHAZYMESIMETHICONEC.B. Fleet Company, Inc.ea04f5a5-cf56-4176-a234-5a73e01ff2182025-10-23WarningsExact identifier
application number: M002
EXTRA STRENGTH gas reliefSIMETHICONERaritan Pharmaceuticals Inc9af45664-adf4-49ce-987d-9314e9804a292025-10-14WarningsExact identifier
application number: M002
Cardinal Health Infants Gas ReliefSIMETHICONECARDINAL HEALTHe0dec270-dabb-4289-b5e0-bf37f9ddcbcd2025-10-14WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI33700cc7-48bc-4174-9f9a-36a50b4c91f32025-10-07WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEChain Drug Marketing Association, Inc.c04422ce-779f-416a-aebf-4ccdfeaaae872025-10-07WarningsExact identifier
application number: M002
HEB Anti Gas Extra StrengthSIMETHICONEHEB71f901c6-b5a4-4115-98f2-628e0b79d7ac2025-10-03WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEHeartland Pharma Co.0860114c-53ec-48bd-a2f2-0b0bf8d2db6e2025-10-03WarningsExact identifier
application number: M002
Pepto Gas plus BloatingSIMETHICONEThe Procter & Gamble Manufacturing Company3d80a5bb-0ed0-769a-e063-6394a90ac50c2025-10-01WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEARMY AND AIR FORCE EXCHANGE SERVICEb59f4848-1cb1-4061-ac79-fccbe85d1d4c2025-09-29WarningsExact identifier
application number: M002
Gas Relief Mint FlavorSIMETHICONERaritan Pharmaceuticals Inc329388cb-3ca1-4ecb-8b50-b1f9e00525592025-09-26WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEPreferred Pharmaceuticals Inc.544106bc-3c80-4d43-9df3-61a931d1751e2025-09-22WarningsExact identifier
application number: M002
EXTRA STRENGTH SIMETHICONESIMETHICONEBi-Martc1b88a30-ffeb-431c-ab73-728cdc786de02025-09-01WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSNb479bf22-3469-7916-e053-2995a90addc83
198857simethicone 66.7 MG/ML Oral SuspensionSCDb479bf22-3469-7916-e053-2995a90addc83
198857simethicone 20 MG per 0.3 ML Oral SuspensionSYb479bf22-3469-7916-e053-2995a90addc83
198857simethicone 40 MG per 0.6 ML Oral SuspensionSYb479bf22-3469-7916-e053-2995a90addc83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69618-059-51696180059511 BOTTLE, DROPPER in 1 CARTON (69618-059-51) / 30 mL in 1 BOTTLE, DROPPER2020-02-010000-00-00NoNoCurrent