Home NDC 55301-680 Gas Relief
Product NDC 55301-680
11-digit product format 553010680
Labeler code 55301
Product ID 55301-680_d2af1d85-93ce-478a-88f6-39d64a576e38
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler ARMY AND AIR FORCE EXCHANGE SERVICE
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-23
Substance DIMETHICONE
Active strength 125 mg/1
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Gas Relief
Brand name suffix Extra Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 125 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55301-680-44 Gas ReliefExtra Strength 2 in 1 CARTON TABLET, CHEWABLE 2 9 55301-680-44 Gas ReliefExtra Strength 9 in 1 BLISTER PACK TABLET, CHEWABLE 9 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55301-680 GAS RELIEF EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE] 8 Current NDC, Legacy NDC, 2 package rows 20240918_b59f4848-1cb1-4061-ac79-fccbe85d1d4c.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 7 of 13 · 255 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cardinal Health Infants Gas Relief SIMETHICONE CARDINAL HEALTH e0dec270-dabb-4289-b5e0-bf37f9ddcbcd 2025-10-14 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE Chain Drug Marketing Association, Inc. c04422ce-779f-416a-aebf-4ccdfeaaae87 2025-10-07 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE Heartland Pharma Co. 0860114c-53ec-48bd-a2f2-0b0bf8d2db6e 2025-10-03 Warnings Exact identifier application number: M002 Gas Relief Ultra Strength SIMETHICONE Preferred Pharmaceuticals Inc. 544106bc-3c80-4d43-9df3-61a931d1751e 2025-09-22 Warnings Exact identifier application number: M002 EXTRA STRENGTH SIMETHICONE SIMETHICONE Bi-Mart c1b88a30-ffeb-431c-ab73-728cdc786de0 2025-09-01 Warnings Exact identifier application number: M002 Quality Choice Infants Gas Relief Dye Free SIMETHICONE QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) 841b85ef-2ac8-4dac-8659-cffb7e1b1e05 2025-08-23 Warnings Exact identifier application number: M002 CVS Health Gas Relief SOFTGEL SIMETHICONE CVS Pharmacy, Inc 2911cac8-45ec-1294-e063-6294a90a4a74 2025-08-22 Warnings Exact identifier application number: M002 TopCare health EXTRA STRENGTH Gas Relief SOFTGEL SIMETHICONE Topco Associates LLC 2ea0eb22-f679-d136-e063-6294a90a1dfe 2025-08-01 Warnings Exact identifier application number: M002 SIMETHICONE INFANT Gas Relief Drops SIMETHICONE AARNA USA Inc. 9b0fde90-35ae-498e-99cc-d120f1a87182 2025-07-29 Warnings Exact identifier application number: M002 Gas Relief Ultra Strength SIMETHICONE Rugby Laboratories, Inc. 24731f4b-ca2b-483f-beed-dfc8104f8133 2025-07-18 Warnings Exact identifier application number: M002 Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONE American Health Packaging 23539e7e-a723-460f-892f-dac5bbbb9b16 2025-07-15 Warnings Exact identifier application number: M002 Curist Gas Relief SIMETHICONE Little Pharma. Inc. 3948c0e5-4ee7-5443-e063-6294a90ad6ae 2025-07-06 Warnings Exact identifier application number: M002 Simethicone 125 mg SIMETHICONE ATLANTIC BIOLOGICALS CORP. 4ce98db3-c7a6-4627-88c5-9de302a53188 2025-06-27 Warnings Exact identifier application number: M002 GNP Regular Strength Gas Relief DIMETHICONE ATLANTIC BIOLOGICALS CORP. b31257ef-489b-4067-9cc6-8a593d983958 2025-06-24 Warnings Exact identifier application number: M002 Gas-X Ultimate Strength Softgels SIMETHICONE Haleon US Holdings LLC 24b777e5-f0b5-400d-8ca9-ae0c04b8503b 2025-05-20 Warnings Exact identifier application number: M002 EXTRA STRENGTH GAS RELIEF SIMETHICONE Geri-Care Pharmaceuticals, Corp b6223134-8a2e-d1ec-e053-2995a90a9077 2025-04-28 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE 125 MG Pioneer Life Sciences, LLC 21e11fe0-b3b9-42f6-a698-9cdc1a6d82bb 2025-04-23 Warnings Exact identifier application number: M002 Gas Relief SIMETHICONE 125 MG NUVICARE LLC 5c6352b9-fd8a-4876-b089-e4c1d15cd264 2025-04-23 Warnings Exact identifier application number: M002 Gas Relief - Cherry Flavor SIMETHICONE TARGET CORPORATION 290fe08d-a0b9-82f7-e063-6394a90a9c75 2025-04-11 Warnings Exact identifier application number: M002 Infants SIMETHICONE ATLANTIC BIOLOGICALS CORP. 27fce442-e328-41d2-bab9-87ab21550c04 2025-04-11 Warnings Exact identifier application number: M002
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55301-680-44 55301068044 2 BLISTER PACK in 1 CARTON (55301-680-44) / 9 TABLET, CHEWABLE in 1 BLISTER PACK 2 blister pack 2021-04-23 0000-00-00 No No Current