FDA.reportPublic FDA data

Anti-Empacho

Product NDC
53145-300
Requested package NDC
53145-300-08
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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53145-30053145-300-08EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
Anti-Empacho
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM BICARBONATE525 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8MDF5V39QOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1305093Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
43807221-58f0-434d-be2d-fa0f54b95db8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-07-28Anti-Empacho
2022-02-18Anti-Empacho
2022-01-28Anti-Empacho
2020-02-04Anti-Empacho
2020-01-31Anti-Empacho

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-300-08Anti-Empacho240 mL in 1 BOTTLELIQUID2409
53145-300-08Anti-Empacho1 in 1 CARTONLIQUID19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.]4
SODIUM CATIONACTIVE MOIETYLYR4M0NH37ANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.]4
IPECACINACTIVE INGREDIENT62I3C8233LANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.]4
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.]4
RHUBARBINACTIVE INGREDIENTG280W4MW6EANTI-EMPACHO (SODIUM BICARBONATE) LIQUID [MENPER DISTRIBUTORS, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RANTI-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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACTIDOSE AQUAACTIVATED CHARCOALPadagis US LLCc85dc235-3f42-4361-9bd2-1aaff798ad752026-07-28WarningsExact identifier
application number: M023
ACTIDOSEACTIVATED CHARCOALPadagis US LLC76e4fe6a-afd4-4f68-b12d-0b094f7506152026-07-28WarningsExact identifier
application number: M023
Anti-EmpachoSODIUM BICARBONATEMenper Distributors, Inc.43807221-58f0-434d-be2d-fa0f54b95db82025-07-22WarningsExact identifier
application number: M023
ndc (package): 53145-300-08
ndc (product): 53145-300
ndc11 (package): 53145030008
INSTA-CHAR AQUEOUSPOISON TREATMENT ADSORBENTVistaPharm, LLCb77f8597-5fd1-4ea9-8e3b-90fe430504252025-01-16WarningsExact identifier
application number: M023
INSTA-CHAR SORBITOLPOISON ADSORBENTVistaPharm, LLCc01b78d7-ea96-4139-9ef6-fb75f760d6252025-01-13WarningsExact identifier
application number: M023
INSTA-CHAR AQUEOUSPOISON TREATMENT ADSORBENTVistaPharm, LLC2e788f55-8a17-43d4-96a6-a76760f638b62025-01-13WarningsExact identifier
application number: M023

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305093sodium bicarbonate 525 MG in 15 mL Oral SolutionPSN43807221-58f0-434d-be2d-fa0f54b95db89
1305093sodium bicarbonate 0.417 MEQ/ML Oral SolutionSCD43807221-58f0-434d-be2d-fa0f54b95db89
1305093NaHCO3 0.417 MEQ/ML Oral SolutionSY43807221-58f0-434d-be2d-fa0f54b95db89
1305093sodium bicarbonate 525 MG per 15 ML Oral SolutionSY43807221-58f0-434d-be2d-fa0f54b95db89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53145-300-08531450300081 BOTTLE in 1 CARTON (53145-300-08) / 240 mL in 1 BOTTLE1 bottle2012-02-210000-00-00NoNoCurrent