NativeRemedies® Cough & Cold Relief Oral Spray

Manufacturer
Silver Star Brands | OHM Pharma
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:29:17

Label at a glance#

ProductCough and Cold Relief
Active ingredientPHOSPHORUS, ZINC PICRATE, POLYGALA SENEGA ROOT, ZINC VALERATE, MERCURIC CHLORIDE, ARSENIC TRIOXIDE, POTASSIUM DICHROMATE, BAPTISIA TINCTORIA, CAUSTICUM, ECHINACEA PURPUREA, ANEMONE PATENS WHOLE, ECHINACEA ANGUSTIFOLIA, POTASSIUM CHLORIDE, SILVER, SOLANUM DULCAMARA FLOWER
Label structure10 sections

Indications and uses

Temporarily relieves symptoms contributing to congestion, coughs, sneezing, headaches, fever & chills. *This statement has not been evaluated by the Food and drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Dosage and administration

Directions: Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Adults and Children 12+: 3 sprays, 3 times per day. childeren 2-12: 2 sprays, 3 times perday. Use additionally as needed, up to 6 times per day.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

HPUS Active Ingredients: Equal volumes of each ingredientin 10X, 30x, 1LM potencies; Arg met, Arsenicum alb, Baptisia, Bryonia, Causticum, Dulcamara, Echinacea angustifolia, Echinacea purp, Kali bic, kali mur, merc corros, Phos, Pulsatilla nutt, Senega, zinc pic, Zinc val.

Uses*

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms contributing to congestion, coughs, sneezing, headaches, fever & chills.

*This statement has not been evaluated by the Food and drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Warnings

WARNINGS SECTION

Warnings:If symptom spersist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a healthcare professional before use. Keep this and all medication out of reach of children. in case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Adults and Children 12+: 3 sprays, 3 times per day. childeren 2-12: 2 sprays, 3 times perday. Use additionally as needed, up to 6 times per day.

OTHER SAFETY INFORMATION

Contains no artificial flavors or colorants. No gluten added.

Tamper resistant for your protection. Use only if saftey seal is intact.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: Purified water, carya ovata bark extract (hickory), citrus extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, as ka healthcare professional before use.

OTC - PURPOSE SECTION

Congestion, Cough, Sneezing, Headaches, Fever & Chills.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cough and cold labelCough and cold label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct 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
68703-345-022023-03-06C16284748780-1d6a99b39-edae-a426-e053-dadaa90af4c2NativeRemedies® Cough & Cold Relief Oral Spray
68703-345-022022-01-28C16284748780-1d6a99b39-edae-a426-e053-dadaa90af4c2NativeRemedies® Cough & Cold Relief Oral Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-345-02Cough and Cold Relief59 mL in 1 BOTTLE, SPRAYSPRAY594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-345COUGH AND COLD RELIEF (ARG MET, ARSENICUM ALB, BAPTISIA, BRYONIA, CAUSTICUM, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURP, KALI BIC, MERC COROS, PHOS, PULSATILLA NUTT, SENEGA, ZINC PIC, ZINC VAL) SPRAY [SILVER STAR BRANDS]4Current NDC, Legacy NDC, 1 package rows20241206_9d4a851c-ebda-1918-e053-2995a90a4936.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-34568703-345-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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
Cough and Cold ReliefARG MET, ARSENICUM ALB, BAPTISIA, BRYONIA, CAUSTICUM, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURP, KALI BIC, MERC COROS, PHOS, PULSATILLA NUTT, SENEGA, ZINC PIC, ZINC VALSilver Star Brands9d4a851c-ebda-1918-e053-2995a90a49362024-12-03WarningsExact identifier
ndc (package): 68703-345-02
ndc (product): 68703-345
ndc11 (package): 68703034502
spl id: 28687e60-9781-0d43-e063-6394a90a03e9
spl set id: 9d4a851c-ebda-1918-e053-2995a90a4936

Reported adverse events (FAERS/openFDA)#

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