FDA.reportPublic FDA data

extra strength Gas Relief cherry creme

Product NDC
46122-811
11-digit product format
461220811
Labeler code
46122
Product ID
46122-811_cd35a0da-817a-42b1-8e3c-1c63d7ef3694
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Amerisource Bergen
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-06
Substance
DIMETHICONE
Active strength
125 mg/1
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
extra strength Gas Relief cherry creme
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O
Rxcui314221

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-811-08extra strength Gas Relief cherry creme9 in 1 BLISTER PACKTABLET, CHEWABLE92
46122-811-08extra strength Gas Relief cherry creme2 in 1 CARTONTABLET, CHEWABLE22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-811-08EA - Each46122-8117d3d95b8-710e-450e-83f9-6240fc62b6de12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-811EXTRA STRENGTH GAS RELIEF CHERRY CREME (SIMETHICONE) TABLET, CHEWABLE [AMERISOURCE BERGEN]2Current NDC, 2 package rows20250110_1e8e8d85-10e2-1273-e063-6394a90a1558.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSN1e8e8d85-10e2-1273-e063-6394a90a15582
314221simethicone 125 MG Chewable TabletSCD1e8e8d85-10e2-1273-e063-6394a90a15582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-811-08461220811082 BLISTER PACK in 1 CARTON (46122-811-08) / 9 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2025-01-07NoNoCurrent