FDA.reportPublic FDA data

Extra Strength Gas Relief Cherry

Product NDC
37808-692
11-digit product format
378080692
Labeler code
37808
Product ID
37808-692_396c78a6-e556-4868-a122-f5cbb6290eb1
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
H E B
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-06
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

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
Extra Strength Gas Relief Cherry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 mg/1

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
314221Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1894fa42-4aaf-2d17-e063-6394a90a3962Available on FDA.report

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
37808-692-13Extra Strength Gas Relief Cherry12 in 1 BLISTER PACKTABLET, CHEWABLE122
37808-692-13Extra Strength Gas Relief Cherry4 in 1 CARTONTABLET, CHEWABLE42
37808-692-73Extra Strength Gas Relief Cherry2 in 1 CARTONTABLET, CHEWABLE22
37808-692-73Extra Strength Gas Relief Cherry9 in 1 BLISTER PACKTABLET, CHEWABLE92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-692EXTRA STRENGTH GAS RELIEF CHERRY (SIMETHICONE) TABLET, CHEWABLE [H E B]2Current NDC, 4 package rows20250210_1894fa42-4aaf-2d17-e063-6394a90a3962.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 13 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-GasSIMETHICONEAllegiant Health7731bd63-667e-4fed-b446-92a4a83b66d62020-11-03WarningsExact identifier
application number: M002
Anti-GasSIMETHICONEMarc Glassman, Inc.e99f2041-2543-4331-9f54-9eea179f94d22020-10-06WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSN1894fa42-4aaf-2d17-e063-6394a90a39622
314221simethicone 125 MG Chewable TabletSCD1894fa42-4aaf-2d17-e063-6394a90a39622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37808-692-13378080692134 BLISTER PACK in 1 CARTON (37808-692-13) / 12 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2025-02-06NoNoCurrent
37808-692-73378080692732 BLISTER PACK in 1 CARTON (37808-692-73) / 9 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2025-02-06NoNoCurrent