FDA.reportPublic FDA data

Athomer Mini Propolis Sterile Isotonic Sea Water Spray

Manufacturer
Nobu Baby LLC | STERGIOULAS, STYLIANOS, & CO. E.E. "PHARMACOSMETIC - DIAFARM"
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:53:03

Label at a glance#

ProductAthomer Propolis
Active ingredientSODIUM CHLORIDE
Label structure9 sections

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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride (0.9%)

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Use

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION 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

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Other information or comments

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

35 ml NDC: 80897-001-35

Inner bottle labelInner bottle labelouter package labelouter package label

100 ml NDC: 80897-001-10

Inner bottle label babyInner bottle label babyouter package label babyouter package label baby

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
351179sodium chloride 0.9 % Nasal SprayPSN3
351179sodium chloride 9 MG/ML Nasal SpraySCD3
351179NaCl 9 MG/ML Nasal SpraySY3
351179sodium chloride 0.9 % Nasal SpraySY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
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
80897-001-102025-01-30C16284748780-12cef2736-8fd7-d83d-e063-dadaa90ab31fAthomer Mini Propolis Sterile Isotonic Sea Water Spray
80897-001-352025-01-30C16284748780-12cef2736-8fd7-d83d-e063-dadaa90ab31fAthomer Mini Propolis Sterile Isotonic Sea Water Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80897-001-10Athomer Propolis100 mL in 1 BOTTLE, SPRAYSPRAY1003
80897-001-35Athomer Propolis35 mL in 1 BOTTLE, SPRAYSPRAY353

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80897-001ATHOMER PROPOLIS (NASAL DECONGESTANT) SPRAY [NOBU BABY LLC]3Legacy NDC, 2 package rows20230111_b34ce02d-9932-6700-e053-2a95a90ad4a6.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80897-00180897-001-35, 80897-001-10

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
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XACTIB
PROPOLIS WAX6Y8XYV2NOFIACT

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
f1f0d8fe-4b65-0079-e053-2a95a90af579b34ce02d-9932-6700-e053-2a95a90ad4a62023-01-10WarningsExact identifier
spl id: f1f0d8fe-4b65-0079-e053-2a95a90af579
spl set id: b34ce02d-9932-6700-e053-2a95a90ad4a6

Reported adverse events (FAERS/openFDA)#

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