Home NDC 53145-300 Anti-Empacho
Product NDC 53145-300
11-digit product format 531450300
Labeler code 53145
Product ID 53145-300_3a8a758e-b2f8-c7ad-e063-6294a90ad6e9
Type HUMAN OTC DRUG
Nonproprietary name Sodium Bicarbonate
Dosage form LIQUID
Route ORAL
Labeler Menper Distributors, Inc.
Application M023
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-02-21
Substance SODIUM BICARBONATE
Active strength 525 mg/15mL
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 2026-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 53145-300 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-300 53145-300-08 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Additional Listing Data#
Finished product Yes
Brand name base Anti-Empacho
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM BICARBONATE 525 mg/15mL
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 1305093 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53145-300-08 Anti-Empacho 240 mL in 1 BOTTLE LIQUID 240 9 53145-300-08 Anti-Empacho 1 in 1 CARTON LIQUID 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM BICARBONATE ACTIVE INGREDIENT 8MDF5V39QO ANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.] 4 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 ANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.] 4 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.] 4 IPECAC INACTIVE INGREDIENT 62I3C8233L ANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.] 4 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B ANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.] 4 RHUBARB INACTIVE INGREDIENT G280W4MW6E ANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R ANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.] 4
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 1 of 1 · 6 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 53145-300-08 53145030008 1 BOTTLE in 1 CARTON (53145-300-08) / 240 mL in 1 BOTTLE 1 bottle 2012-02-21 0000-00-00 No No Current