FDA.reportPublic FDA data

ALLERGY POLLEN

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2022-02-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:16:15

Label at a glance#

ProductALLERGY POLLEN
Active ingredientGARLIC, ECHINACEA ANGUSTIFOLIA, SOLIDAGO VIRGAUREA FLOWERING TOP, TOXICODENDRON PUBESCENS LEAF, ONION, AMBROSIA ARTEMISIIFOLIA, APIS MELLIFERA, ARSENIC TRIOXIDE, ARSENIC TRIIODIDE, EUPHRASIA STRICTA, IODINE, HISTAMINE DIHYDROCHLORIDE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, STRYCHNOS NUX-VOMICA SEED, SUS SCROFA PITUITARY GLAND, POSTERIOR, ANEMONE PULSATILLA, SCHOENOCAULON OFFICINALE SEED, SULFUR
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (HPUS*) - equal amounts of: Allium Sat 8X, Echinacea Ang 8X, Solidago 8X, Rhus Tox 12X, Allium Cepa 30C, Ambrosia 30C, Apis Mel 30C, Arsenicum Alb 30C, Euphrasia 30C, Iodium 30C, Histaminum Muriaticum 30C,  Lycopodium 30C, Merc Solub 30C, Nux Vomica 30C, Pituitaria Glandula 30C, Pulsatilla 30C, Sabadilla 30C, Sulphur 30C.

OTC - PURPOSE SECTION

Uses:  Temporarily relieves stuffiness, nasal discharge, watery eyes, &/or other symptoms related to allergies/hay fever.**

INDICATIONS & USAGE SECTION

Uses:  Temporarily relieves stuffiness, nasal discharge, watery eyes, &/or other symptoms related to allergies/hay fever.**

DOSAGE & ADMINISTRATION SECTION

Directions:  Adults & children above 12 years:  10 drops orally 3 times daily, or as directed by a health care professional.

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 care 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:  Ethyl Alcohol USP, Purified Water.

OTC - QUESTIONS SECTION

Questions & Comments?

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

REFERENCES SECTION

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0588-1

ALLERGY POLLEN

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

UPC: 877730000583 NON GMO Logo

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0588-12022-02-11C16284748780-1d6a99b39-6c5d-a426-e053-dadaa90af4c2ALLERGY POLLEN
43406-0588-12022-01-28C16284748780-1d6a99b39-6c5d-a426-e053-dadaa90af4c2ALLERGY POLLEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0588-1ALLERGY POLLEN30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0588ALLERGY POLLEN (GARLIC, ECHINACEA ANGUSTIFOLIA, SOLIDAGO VIRGAUREA FLOWERING TOP, TOXICODENDRON PUBESCENS LEAF, ONION, AMBROSIA ARTEMISIIFOLIA, APIS MELLIFERA, ARSENIC TRIOXIDE, ARSENIC TRIIODIDE, EUPHRASIA STRICTA, IODINE, HISTAMINE DIHYDROCHLORIDE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, STRYCHNOS NUX-VOMICA SEED, SUS SCROFA PITUITARY GLAND POSTERIOR, ANEMONE PULSATILLA, SCHOENOCAULON OFFICINALE SEED, SULFUR) LIQUID [NATURAL CREATIONS, INC.]4Current NDC, Legacy NDC, 1 package rows20220212_bbf000a5-3528-41d7-b109-6ab9ea087d6d.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-058843406-0588-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GARLICV1V998DC17ACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ONION492225Q21HACTIB
AMBROSIA ARTEMISIIFOLIA9W34L2CQ9AACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ARSENIC TRIIODIDE3029988O2TACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
IODINE9679TC07X4ACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SUS SCROFA PITUITARY GLAND, POSTERIORE8S87O660TACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
SULFUR70FD1KFU70ACTIB
ALCOHOL3K9958V90MIACT
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
ALLERGY POLLENGARLIC, ECHINACEA ANGUSTIFOLIA, SOLIDAGO VIRGAUREA FLOWERING TOP, TOXICODENDRON PUBESCENS LEAF, ONION, AMBROSIA ARTEMISIIFOLIA, APIS MELLIFERA, ARSENIC TRIOXIDE, ARSENIC TRIIODIDE, EUPHRASIA STRICTA, IODINE, HISTAMINE DIHYDROCHLORIDE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, STRYCHNOS NUX-VOMICA SEED, SUS SCROFA PITUITARY GLAND POSTERIOR, ANEMONE PULSATILLA, SCHOENOCAULON OFFICINALE SEED, SULFURNatural Creations, Inc.bbf000a5-3528-41d7-b109-6ab9ea087d6d2022-02-11WarningsExact identifier
ndc (package): 43406-0588-1
ndc (product): 43406-0588
ndc11 (package): 43406058801
spl id: cf3e478d-c7b5-4988-92df-fa23a29f5057
spl set id: bbf000a5-3528-41d7-b109-6ab9ea087d6d

Reported adverse events (FAERS/openFDA)#

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