FDA.reportPublic FDA data

ATHOMER baby STERILE ISOTONIC SEA WATER SPRAY PROPOLIS

Manufacturer
PHARMACOSMETIC-DIAFARM
Effective date
2014-11-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:40:49

Label at a glance#

ProductAthomer baby
Active ingredientSODIUM CHLORIDE
Label structure9 sections

Indications and uses

For cleaning the nasal cavity and the removal of the unpleasant mucus. For nasal irrigation

Dosage and administration

For the liquidation and removal of the unpleasant mucus, apply at least 4 sprayings in each nostril up to 4 times per day For preventative daily use, apply 1 to 2 sprayings in each nostril every day Suitable for repeated long-term use Shake well before each use

Storage and handling

Store at room temperature between 68° and 77° F (20° to 25°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Purified Sea Water		Purpose
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • For cleaning the nasal cavity and the removal of the unpleasant mucus.
  • For nasal irrigation

Warnings

WARNINGS SECTION

  • For external use only
  • Use only as directed
  • The use of this dispenser by more than one person may spread infection
  • If you are pregnant or breastfeeding, seek guidance from a healthcare professional

Directions

OTC - PURPOSE SECTION

  • For the liquidation and removal of the unpleasant mucus, apply at least 4 sprayings in each nostril up to 4 times per day
  • For preventative daily use, apply 1 to 2 sprayings in each nostril every day
  • Suitable for repeated long-term use
  • Shake well before each use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Other information

STORAGE AND HANDLING SECTION

Store at room temperature between 68° and 77° F (20° to 25°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water
Propolis

PRINCIPAL DISPLAY PANEL - 100 mL carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ATHOMER

baby

STERILE ISOTONIC
SEA WATER
SPRAY

NASAL HYGIENE
AND CLEANNESS

PROPOLIS

ABSOLUTELY
NATURAL PRODUCT

100 mL

Carton
Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
351179sodium chloride 0.9 % Nasal SprayPSN2
351179sodium chloride 9 MG/ML Nasal SpraySCD2
351179NaCl 9 MG/ML Nasal SpraySY2
351179sodium chloride 0.9 % Nasal SpraySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54753-003-102020-01-31C16284748780-19d75b9d0-bec0-f424-e053-dadaa90a57ceATHOMER baby STERILE ISOTONIC SEA WATER SPRAY PROPOLIS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54753-003-10Athomer baby1 in 1 CARTONSPRAY12
54753-003-10Athomer baby100 mL in 1 BOTTLE, SPRAYSPRAY1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54753-003ATHOMER BABY (SODIUM CHLORIDE) SPRAY [PHARMACOSMETIC-DIAFARM]2Legacy NDC, 2 package rows20141114_54b3476b-23fc-4323-b6ef-04362e6dff23.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X2
SODIUM CATIONACTIVE MOIETYLYR4M0NH372
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOF2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54753-00354753-003-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB
PROPOLIS WAX6Y8XYV2NOFIACT
WATER059QF0KO0RIACT

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
46fa8d8e-7a0c-4498-8a95-22823f452f8254b3476b-23fc-4323-b6ef-04362e6dff232014-11-04WarningsExact identifier
spl id: 46fa8d8e-7a0c-4498-8a95-22823f452f82
spl set id: 54b3476b-23fc-4323-b6ef-04362e6dff23

Reported adverse events (FAERS/openFDA)#

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