FDA.reportPublic FDA data

Sodium Bicarbonate

Manufacturer
World Perfumes Inc
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:54:13

Label at a glance#

ProductSodium Bicarbonate
Active ingredientSODIUM BICARBONATE
Label structure12 sections

Dosage and administration

Adults and children 12 years of age and over. Mix 1/4 Teaspoonful in water and drink. Do not use more than 4 times a day. For children under 12 years of age - ask a doctor

Storage and handling

Store at controlled room temperature 15- 25C (59- 86F) This package is sold by weight, not volume Some setting of contents may have occured during shipping and handling

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Sodium Bicarbonate 100%. Purpose: Antacid

Purpose

OTC - PURPOSE SECTION

Antacid

Use

INDICATIONS & USAGE SECTION

For the relief of heartburn, sour stomach, acid ingestion and upset stomach associated with these symptoms.

Warnings

WARNINGS SECTION

Do not take more than maximum daily dosage. Do not take more than four 1/4 teaspoonfuls in a 24 hour period. Do not use the maximum dosage of this product for more than 2 weeks. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if you are on a sodium restricted diet. If preganat of breast feeding, ask a health professional before use.

Do not use

OTC - DO NOT USE SECTION

  • If you are on sodium restricted diet

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT REACH OF CHILDREN

Additional Warnings

WARNINGS AND PRECAUTIONS SECTION

Stomach Warning: To avoid serious injury, do not take until powder is completely dissolved. it is very important not to take this product when overly full from food or drink. Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and over. Mix 1/4 Teaspoonful in water and drink.
  • Do not use more than 4 times a day.
  • For children under 12 years of age - ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 15- 25C (59- 86F)
  • This package is sold by weight, not volume
  • Some setting of contents may have occured during shipping and handling

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Tamper-Evident Disclosure:

OTHER SAFETY INFORMATION

Do nt use if over-wrap bottle cap is torn broken or missing.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Complete LabelComplete Label6 fl oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1488624sodium bicarbonate 2.6 GM Powder for Oral SolutionPSN5
1488624sodium bicarbonate 2600 MG Powder for Oral SolutionSCD5
1488624NaHCO3 2600 MG Powder for Oral SolutionSY5
1488624sodium bicarbonate 2.6 GM Powder for Oral SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10095-100-012025-02-01C16284748780-12cef2736-77ef-d83d-e063-dadaa90ab31fDR SANA SODIUM BICARBONATE 6oz
10095-100-022025-02-01C16284748780-12cef2736-77ef-d83d-e063-dadaa90ab31fDR SANA SODIUM BICARBONATE 6oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10095-100-01Sodium Bicarbonate113 g in 1 BOTTLEPOWDER1135
10095-100-02Sodium Bicarbonate170 g in 1 BOTTLEPOWDER1705

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10095-100SODIUM BICARBONATE POWDER [WORLD PERFUMES INC]5Current NDC, Legacy NDC, 2 package rows20250202_a83544e4-ec09-1e95-e053-2995a90ab7b9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10095-10010095-100-01, 10095-100-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BICARBONATE IONHN1ZRA3Q20IACT
SODIUM BICARBONATE8MDF5V39QOACTIB

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium BicarbonateSODIUM BICARBONATEWorld Perfumes Inca83544e4-ec09-1e95-e053-2995a90ab7b92025-01-15WarningsExact identifier
ndc (package): 10095-100-02
ndc (package): 10095-100-01
ndc (product): 10095-100
ndc11 (package): 10095010001
ndc11 (package): 10095010002
spl id: 2bc167c0-5b09-b492-e063-6294a90a728f
spl set id: a83544e4-ec09-1e95-e053-2995a90ab7b9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.