FDA.reportPublic FDA data

TEENY TUMMY

Product NDC
17856-1141
11-digit product format
178561141
Labeler code
17856
Product ID
17856-1141_37b26063-ea95-7741-e063-6394a90a79a8
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-04
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

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
TEENY TUMMY
Brand name suffix
Gas Relief Drops
Listing expiration
2026-12-31

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 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
376660a2-becb-48cf-a9f5-6a76a8b8ca70Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1141-1TEENY TUMMYGas Relief Drops120 in 1 BOX, UNIT-DOSESUSPENSION1204
17856-1141-2TEENY TUMMYGas Relief Drops120 in 1 BOX, UNIT-DOSESUSPENSION1204
17856-1141-3TEENY TUMMYGas Relief Drops120 in 1 BOX, UNIT-DOSESUSPENSION1204
17856-1141-4TEENY TUMMYGas Relief Drops120 in 1 BOX, UNIT-DOSESUSPENSION1204
17856-1141-5TEENY TUMMYGas Relief Drops2 mL in 1 SYRINGESUSPENSION24
17856-1141-5TEENY TUMMYGas Relief Drops120 in 1 BOX, UNIT-DOSESUSPENSION1204
17856-1141-6TEENY TUMMYGas Relief Drops0.3 mL in 1 SYRINGESUSPENSION0.34
17856-1141-7TEENY TUMMYGas Relief Drops0.3 mL in 1 SYRINGESUSPENSION0.34
17856-1141-8TEENY TUMMYGas Relief Drops0.6 mL in 1 SYRINGESUSPENSION0.64
17856-1141-9TEENY TUMMYGas Relief Drops0.6 mL in 1 SYRINGESUSPENSION0.64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-1141-1EA - Each17856-114153429f82-f3ec-434d-af53-609f1d520dd012025-03-04
17856-1141-2EA - Each17856-11417066e3eb-2e10-40c7-ba02-6b0eaab925d512025-03-04
17856-1141-3EA - Each17856-114153ac2e8a-9999-4f28-8486-bb05a5e265f512025-03-04
17856-1141-4EA - Each17856-114188f1a33a-5403-4e61-9245-f267d10f6d9c12025-03-04
17856-1141-5ML - Milliliter17856-11416154db0e-4846-4ec3-96f5-5c281a7a75f212026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1141TEENY TUMMY GAS RELIEF DROPS (SIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORP]1Current NDC, 10 package rows20240913_376660a2-becb-48cf-a9f5-6a76a8b8ca70.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 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.396903dc-ae2d-4bf4-b1fd-0017b84abef92024-02-28WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.44730cbd-5b98-49bd-b3b8-6fecb0ccd1532024-02-28WarningsExact identifier
application number: M
HYDROCORTISONEHYDROCORTISONE ACETATEHART Health779f945f-ab69-40de-8d86-ab76debc5c7c2024-02-16WarningsExact identifier
application number: M
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Healthf5746bba-9d7f-4691-b466-14985473bf142024-02-16WarningsExact identifier
application number: M
IBUPROFENIBUPROFENHART Health1c1374e1-890f-48ab-8f93-e84da9d5bf842024-01-25WarningsExact identifier
application number: M
Hand SanitizerANTISEPTIC GELHART Healthf07daf29-d0db-4cf8-8baf-d175c2b2ef502024-01-25WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEHART Health0346a322-8f6e-405a-8d17-8bc6ce5105a32024-01-24WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLNorMed441b915a-287f-4734-b4d9-730b3d95e04c2024-01-24WarningsExact identifier
application number: M
Sooth-a-StingBENZOCAINEHART Healthbd7229b6-813a-4149-bfe2-fe682f270ff42024-01-18WarningsExact identifier
application number: M
First AidBENZALKONIUM CHLORIDE, BENZOCAINEHART Healtha6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a2024-01-18WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthd8f175f9-f526-4c73-a171-49309ca16cb02024-01-18Warnings, Adverse reactionsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN376660a2-becb-48cf-a9f5-6a76a8b8ca704
198857simethicone 66.7 MG/ML Oral SuspensionSCD376660a2-becb-48cf-a9f5-6a76a8b8ca704
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY376660a2-becb-48cf-a9f5-6a76a8b8ca704
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY376660a2-becb-48cf-a9f5-6a76a8b8ca704

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-1141-117856114101120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1141-1) / .3 mL in 1 SYRINGE (17856-1141-6) 120 syringe2024-09-12NoNoCurrent
17856-1141-217856114102120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1141-2) / .3 mL in 1 SYRINGE (17856-1141-7) 120 syringe2024-09-12NoNoCurrent
17856-1141-317856114103120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1141-3) / .6 mL in 1 SYRINGE (17856-1141-8) 120 syringe2024-09-12NoNoCurrent
17856-1141-417856114104120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1141-4) / .6 mL in 1 SYRINGE (17856-1141-9) 120 syringe2024-09-12NoNoCurrent
17856-1141-517856114105120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1141-5) / 2 mL in 1 SYRINGE120 syringe2025-05-30NoNoCurrent
17856-1141-6178561141060.3 mL in 1 SYRINGE0.3 mlHistorical
17856-1141-7178561141070.3 mL in 1 SYRINGE0.3 mlHistorical
17856-1141-8178561141080.6 mL in 1 SYRINGE0.6 mlHistorical
17856-1141-9178561141090.6 mL in 1 SYRINGE0.6 mlHistorical