FDA.reportPublic FDA data

TEENY TUMMY

Product NDC
71399-0041
11-digit product format
713990041
Labeler code
71399
Product ID
71399-0041_0b72faec-a588-460c-8339-a32b5fbf26b4
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Akron Pharma
Application
M002
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

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 Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui198857

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-0041-12025-02-11C16284748780-12cef2736-b5ab-d83d-e063-dadaa90ab31fTEENY TUMMY fast instant gas relief INFANT'S GAS RELIEF DROPS
71399-0041-12025-01-30C16284748780-12cef2736-b5ab-d83d-e063-dadaa90ab31fTEENY TUMMY fast instant gas relief INFANT'S GAS RELIEF DROPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0041-1TEENY TUMMYGas Relief Drops30 mL in 1 BOTTLESUSPENSION303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0041-1ML - Milliliter71399-0041bd63ce1b-e945-4f68-976c-8cd01a82c4a212023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0041TEENY TUMMY GAS RELIEF DROPS (SIMETHICONE) SUSPENSION [AKRON PHARMA]2Current NDC, 1 package rows20250213_dcdd0daf-5ef0-4cb2-872d-89ed6e9f6d60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN05eadb73-4468-4dae-a67b-133d893feed25
198857simethicone 66.7 MG/ML Oral SuspensionSCD05eadb73-4468-4dae-a67b-133d893feed25
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY05eadb73-4468-4dae-a67b-133d893feed25
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY05eadb73-4468-4dae-a67b-133d893feed25
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
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSNdcdd0daf-5ef0-4cb2-872d-89ed6e9f6d603
198857simethicone 66.7 MG/ML Oral SuspensionSCDdcdd0daf-5ef0-4cb2-872d-89ed6e9f6d603
198857simethicone 20 MG per 0.3 ML Oral SuspensionSYdcdd0daf-5ef0-4cb2-872d-89ed6e9f6d603
198857simethicone 40 MG per 0.6 ML Oral SuspensionSYdcdd0daf-5ef0-4cb2-872d-89ed6e9f6d603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71399-0041-17139900410130 mL in 1 BOTTLE (71399-0041-1) 30 ml2023-08-04NoNoCurrent