FDA.reportPublic FDA data

COLD/FLU HP

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc
Effective date
2025-11-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:35:16

Label at a glance#

ProductCOLD/FLU HP
Active ingredientARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, BRYONIA ALBA ROOT, SOLANUM DULCAMARA TOP, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM FLOWERING TOP, FERROSOFERRIC PHOSPHATE, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, SULFUR, ZINC ACETATE ANHYDROUS, ZINC CARBONATE, ZINC, ZINC CHLORIDE, ZINC OXIDE, ZINC PICRATE NONAHYDRATE, ZINC VALERATE DIHYDRATE, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) WHOLE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*): Arsenicum Album 10X, 30X, 100X, Baptisia Tinctoria 10X, 30X, 100X,Bryonia Alba 10X, 30X, 100X, Dulcamara 10X, 30X, 100X, Echinacea Angustifolia 10X, 30X, 100X, Echinacea Purpurea 10X, 30X, 100X, Eupatorium Perfoliatum 10X, 30X, 100X, Ferrum Phosphoricum 10X, 30X, 100X, Gelsemium Sempervirens 10X, 30X, 100X, Kali Muriaticum 10X, 30X, 100X, Phosphorus 10X, 30X, 100X, Pulsatilla 10X, 30X, 100X, Sulphur 10X, 30X, 100X, Zincum Aceticum 10X, 30X, 100X, Zincum Carbonicum 10X, 30X, 100X, Zincum Metallicum 10X, 30X, 100X, Zincum Muriaticum 10X, 30X, 100X, Zincum Oxydatum 10X, 30X, 100X, Zincum Picricum 10X, 30X, 100X, Zincum Val 10X, 30X, 100X, Anas Barbariae 50C, 100C, 200C, Influenzinum 50C, 100C, 200C.

OTC - PURPOSE SECTION

USES: Temporarily relieves minor symptoms of cold and/or flu.**

INDICATIONS & USAGE SECTION

USES: Temporarily relieves minor symptoms of cold and/or flu.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & childern above 12 years: 1-6 sprays orally four times daily. Initially can be taken every 15 minutes for the first 3-6 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Citric Acid, Glycerin USP, Potassium Sorbate, Purified Water.

OTC - QUESTIONS SECTION

QUESTION & COMMENTS?

Natural Creations Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

*The letters "HPUS" indicate the components in this product are officially monograohed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted mediacl evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0670-2

COLD/FLU HP

Homeopathic

2 fl oz (60 mL)

877730004871

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130877730004871GTIN-13: 0877730004871
EAN-13: 0877730004871
GTIN-12: 877730004871
UPC-A: 877730004871
GTIN storage (14 digits): 00877730004871		COLD FLU HP.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
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
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
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
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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
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
43406-0670-22023-01-10C16284748780-1d6a99b39-d373-a426-e053-dadaa90af4c2COLD/FLU HP
43406-0670-22022-01-28C16284748780-1d6a99b39-d373-a426-e053-dadaa90af4c2COLD/FLU HP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0670-2COLD/FLU HP60 mL in 1 BOTTLE, SPRAYLIQUID604

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-067043406-0670-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
ECHINACEA PURPUREAQI7G114Y98ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIM
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SULFUR70FD1KFU70ACTIB
ZINC ACETATE ANHYDROUSH2ZEY72PMEACTIM
ZINC CARBONATEEQR32Y7H0MACTIB
ZINCJ41CSQ7QDSACTIB
ZINC CHLORIDE86Q357L16BACTIM
ZINC OXIDESOI2LOH54ZACTIM
ZINC PICRATE NONAHYDRATE0057VRD75NACTIB
ZINC VALERATE DIHYDRATEMN0RX54EQAACTIB
CAIRINA MOSCHATA HEART/LIVER AUTOLYSATERN2HC612GYACTIB
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) WHOLEFACIFOJ3Z7ACTIB
CITRIC ACID ACETATEDSO12WL7AUIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
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
COLD/FLU HPARSENICTRIOXIDE,BAPTISIATINCTORIAROOT,BRYONIAALBAROOT,SOLANUMDULCAMARATOP,ECHINACEAANGUSTIFOLIA,ECHINACEAPURPUREA,EUPATORIUMPERFOLIATUMFLOWERINGTOP,FERROSOFERRICPHOSPHATE,GELSEMIUMSEMPERVIRENSROOT,POTASSIUMCHLORIDE,PHOSPHORUS,ANEMONEPULSATILLA,SULFUR,ZINCACETATEANHYDROUS,ZINCCARBONATE,ZINC,ZINCCHLORIDE,ZINCOXIDE,ZINCPICRATENONAHYRDATE,ZINCVALERATEDIHYDRATE,CAIRINAMOSCHATAHEART/LIVERAUTOLYSATE,INFLUENZINUMNatural Creations, Inc.11d945ea-3b03-42cc-b1c0-e4c517e386f62025-11-20WarningsExact identifier
ndc (package): 43406-0670-2
ndc (product): 43406-0670
ndc11 (package): 43406067002
spl id: ee60e9c8-141a-4dae-bfc5-417b83c09f73
spl set id: 11d945ea-3b03-42cc-b1c0-e4c517e386f6

Reported adverse events (FAERS/openFDA)#

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