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 1 of 13 · 256 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimethiconeSIMETHICONESOFTGEL HEALTHCARE PRIVATE LIMITED322e6cb3-0ddc-9300-e063-6294a90a972a2026-07-18WarningsExact identifier
application number: M002
Best ChoiceSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)245504a6-d2fc-4e05-871b-bab03f34e1542026-07-17WarningsExact identifier
application number: M002
Best Choice Extra StrengthSIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)a41b2895-abbe-4cf1-9c42-0b5e902d298b2026-07-17WarningsExact identifier
application number: M002
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4bd53a70-3ba0-364c-e063-6394a90a7a642026-07-16WarningsExact identifier
application number: M002
FEVIA Gas ControlSIMETHICONEVIVUNT PHARMA LLC4b1d1bce-eeef-b790-e063-6294a90a166e2026-07-16WarningsExact identifier
application number: M002
Maximum Strength Antacid MintSIMETHICONEGuardian Drug Company48ec3132-17cf-1de9-e063-6294a90aa4072026-07-14WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER 70000cce7f7db-99b8-4d7d-ac77-43da6323ebe12026-07-14WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONERite Aid Corporation43e94ffc-a3ec-4a16-98db-b000a6dc42302026-07-10WarningsExact identifier
application number: M002
Tea Tree Oil AntifungalTOLNAFTATEGuangzhou ChuanMa International Trading Co.,Ltd.55a48fc6-1963-66ea-e063-6294a90a35012026-07-02WarningsExact identifier
application number: M002
RIGHT REMEDIES Extra Strength Gas ReliefSIMETHICONEStrive Pharmaceuticals Inc.2d651784-a17b-12bc-e063-6294a90a8ab22026-06-30WarningsExact identifier
application number: M002
Gas ReliefGAS RELIEFChain Drug Marketing Association, Inc.912f896b-ff49-40e6-b425-c314e0cbf48e2026-06-30WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLC0add7687-f9d7-4f70-b9a8-1454db8a7caf2026-06-29WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)447ee411-f4b9-4dd1-a3e0-36ad79bccbf92026-06-25WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAmerisourceBergen (Good Neighbor Pharmacy) 4612233bee4db-d4aa-4c72-8eeb-46ff374a92a62026-06-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEP & L Development, LLCf4526eba-e6d0-44de-99ea-4af7a6dba1992026-06-10WarningsExact identifier
application number: M002
SIMETHICONESIMETHICONEYYBA50250112-933c-ffb1-e063-6394a90aaafb2026-06-09WarningsExact identifier
application number: M002
INFANTS GAS RELIEFSIMETHICONEMollec Inc53705dbc-daca-2214-e063-6294a90a10972026-06-04WarningsExact identifier
application number: M002
Childrens Simethicone DropsCHILDRENS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma6e26ffbe-4c5b-4689-99bc-88b39ed40a252026-06-04WarningsExact identifier
application number: M002
Infants Simethicone DropsINFANTS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma235f458e-c275-4bc1-9c0f-e007c40406492026-06-03WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONECare One (Retail Business Services, LLC.)5e2b25a0-eddf-4d58-927f-bc72c0a92c882026-06-02WarningsExact 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