Home NDC 69256-520 Infants Gas relief
Product NDC 69256-520
11-digit product format 692560520
Labeler code 69256
Product ID 69256-520_f5b221f3-ed1c-4c22-ab5d-c6b846950b32
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form SOLUTION/ DROPS
Route ORAL
Labeler Harris Teeter, LLC
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-05
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 Infants Gas relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 20 mg/.3mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69256-520-09 Infants Gas relief 1 in 1 CARTON SOLUTION/ DROPS 1 2 69256-520-09 Infants Gas relief 30 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69256-520 INFANTS GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [HARRIS TEETER, LLC] 2 Current NDC, 2 package rows 20250207_2c39de90-4896-8a85-e063-6394a90af677.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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69256-520-09 69256052009 1 BOTTLE, DROPPER in 1 CARTON (69256-520-09) / 30 mL in 1 BOTTLE, DROPPER 2025-02-05 No No Current