Home NDC 0132-0211 PHAZYME
Product NDC 0132-0211
11-digit product format 001320211
Labeler code 0132
Product ID 0132-0211_59b75f9e-58e1-46f2-b704-99b93f93a90e
Type HUMAN OTC DRUG
Nonproprietary name Simethicone
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler C.B. Fleet Company, Inc.
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-04-01
Substance DIMETHICONE
Active strength 250 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 PHAZYME
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 250 mg/1
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 412111 Internal RxNorm lookup 1537320 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0132-0211-12 PHAZYME 12 in 1 BLISTER PACK CAPSULE, GELATIN COATED 12 10 0132-0211-12 PHAZYME 1 in 1 BOX CAPSULE, GELATIN COATED 1 10 0132-0211-24 PHAZYME 2 in 1 BOX CAPSULE, GELATIN COATED 2 10 0132-0211-24 PHAZYME 12 in 1 BLISTER PACK CAPSULE, GELATIN COATED 12 10 0132-0211-36 PHAZYME 12 in 1 BLISTER PACK CAPSULE, GELATIN COATED 12 10 0132-0211-36 PHAZYME 3 in 1 BOX CAPSULE, GELATIN COATED 3 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIMETHICONE ACTIVE INGREDIENT 92RU3N3Y1O PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.] 4 DIMETHICONE ACTIVE MOIETY 92RU3N3Y1O PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.] 4 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.] 4 GELATIN INACTIVE INGREDIENT 2G86QN327L PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0132-0211 PHAZYME (SIMETHICONE) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.] 9 Current NDC, Legacy NDC, 6 package rows 20241215_ea04f5a5-cf56-4176-a234-5a73e01ff218.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 5 of 13 · 242 matching rows.
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 0132-0211-12 00132021112 1 BLISTER PACK in 1 BOX (0132-0211-12) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK 1 blister pack 2014-04-01 0000-00-00 No No Current 0132-0211-24 00132021124 2 BLISTER PACK in 1 BOX (0132-0211-24) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK 2 blister pack 2014-04-01 0000-00-00 No No Current 0132-0211-36 00132021136 3 BLISTER PACK in 1 BOX (0132-0211-36) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK 3 blister pack 2014-04-01 0000-00-00 No No Current