Home NDC 71610-669 Sodium Bicarbonate Antacid
Product NDC 71610-669
11-digit product format 716100669
Labeler code 71610
Product ID 71610-669_4db6a586-dc28-33bb-e063-6394a90abc9b
Type HUMAN OTC DRUG
Nonproprietary name Sodium Bicarbonate
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-03-25
Substance SODIUM BICARBONATE
Active strength 650 mg/1
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 71610-669-80 excluded package package 71610-669-60 excluded package package 71610-669-53
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 Sodium Bicarbonate Antacid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM BICARBONATE 650 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8MDF5V39QO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198861 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 71610-669-53 Sodium Bicarbonate Antacid 60 in 1 BOTTLE TABLET 60 3 71610-669-60 Sodium Bicarbonate Antacid 90 in 1 BOTTLE TABLET 90 3 71610-669-80 Sodium Bicarbonate Antacid 180 in 1 BOTTLE TABLET 180 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-669 SODIUM BICARBONATE ANTACID (SODIUM BICARBONATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Current NDC, Legacy NDC, 3 package rows 20250112_bba7d5bf-c94b-4ee4-a399-9a2818d84c78.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 8 of 34 · 678 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 71610-669-53 71610066953 60 TABLET in 1 BOTTLE (71610-669-53) 60 tablet 2022-10-18 0000-00-00 No No Current 71610-669-60 71610066960 90 TABLET in 1 BOTTLE (71610-669-60) 90 tablet 2022-10-18 0000-00-00 No No Current 71610-669-80 71610066980 180 TABLET in 1 BOTTLE (71610-669-80) 180 tablet 2022-10-18 0000-00-00 No No Current