Home NDC 67777-402 Saline Enema
Product NDC 67777-402
11-digit product format 677770402
Labeler code 67777
Product ID 67777-402_351f54a7-a9af-92ca-e063-6394a90a6ce6
Type HUMAN OTC DRUG
Nonproprietary name Sodium Phosphate Monobasic, Sodium Phosphate Dibasic
Dosage form ENEMA
Route RECTAL
Labeler Dynarex Corporation
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-08-29
Substance SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC
Active strength 7; 19 g/118mL; g/118mL
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 Saline Enema
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM PHOSPHATE, DIBASIC 7 g/118mL SODIUM PHOSPHATE, MONOBASIC 19 g/118mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GR686LBA74 Internal UNII lookup 3980JIH2SW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283100 Internal RxNorm 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 67777-402-01 Saline Enema 1 in 1 BOX ENEMA 1 9 67777-402-01 Saline Enema 133 mL in 1 BOTTLE ENEMA 133 9 67777-402-02 Saline Enema 48 in 1 CASE ENEMA 48 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM PHOSPHATE, DIBASIC ACTIVE INGREDIENT GR686LBA74 SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC) ENEMA [DYNAREX CORPORATION] 4 SODIUM PHOSPHATE, MONOBASIC ACTIVE INGREDIENT 3980JIH2SW SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC) ENEMA [DYNAREX CORPORATION] 4 PHOSPHATE ION ACTIVE MOIETY NK08V8K8HR SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC) ENEMA [DYNAREX CORPORATION] 4 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC) ENEMA [DYNAREX CORPORATION] 4 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC) ENEMA [DYNAREX CORPORATION] 4 WATER INACTIVE INGREDIENT 059QF0KO0R SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC) ENEMA [DYNAREX CORPORATION] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67777-402 SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC) ENEMA [DYNAREX CORPORATION] 9 Current NDC, Legacy NDC, 3 package rows 20250516_7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5.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 14 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 283100 sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML Enema PSN 7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5 9 283100 sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema SCD 7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5 9 283100 sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema SY 7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5 9 283100 sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema SY 7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5 9
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67777-402-01 67777040201 1 BOTTLE in 1 BOX (67777-402-01) > 118 mL in 1 BOTTLE 1 bottle 2012-08-29 0000-00-00 No No Current 67777-402-02 67777040202 48 BOX in 1 CASE (67777-402-02) / 1 BOTTLE in 1 BOX (67777-402-01) / 133 mL in 1 BOTTLE 48 box 2012-08-29 0000-00-00 No No Current