Pollen Distress

Product NDC
50845-0270
11-digit product format
508450270
Labeler code
50845
Product ID
50845-0270_1858a1f0-ba02-4fd0-af56-0673e0b4af17
Type
HUMAN OTC DRUG
Nonproprietary name
Allium Cepa, Apis Mellifica, Aralia Racemosa, Arundo Mauritanica, Baptisia Tinctoria, Echinacea (Angustifolia), Euphrasia Officinalis, Gelsemium Sempervirens, Histaminum Hydrochloricum, Lycopodium Clavatum, Rhus Tox, Sabadilla, Sanguinaria Canadensis, Urtica Urens
Dosage form
SPRAY
Route
ORAL
Labeler
Liddell Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-12-07
Marketing end
2027-04-06
Substance
APIS MELLIFERA; ARALIA RACEMOSA ROOT; ARUNDO PLINIANA ROOT; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; ONION; SANGUINARIA CANADENSIS ROOT; SCHOENOCAULON OFFICINALE SEED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS WHOLE
Active strength
3; 6; 30; 3; 4; 6; 200; 12; 6; 6; 200; 6; 200; 3 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pollen Distress

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA3 [hp_X]/mL
ARALIA RACEMOSA ROOT6 [hp_X]/mL
ARUNDO PLINIANA ROOT30 [hp_C]/mL
BAPTISIA TINCTORIA ROOT3 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE4 [hp_X]/mL
EUPHRASIA STRICTA6 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT200 [hp_C]/mL
HISTAMINE DIHYDROCHLORIDE12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE6 [hp_X]/mL
ONION6 [hp_X]/mL
SANGUINARIA CANADENSIS ROOT200 [hp_C]/mL
SCHOENOCAULON OFFICINALE SEED6 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF200 [hp_C]/mL
URTICA URENS WHOLE3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S82P3R43Z, T90W4582DU, ZXE7LB03WC, 5EF0HWI5WU, VB06AV5US8, C9642I91WL, 639KR60Q1Q, 3POA0Q644U, C88X29Y479, 492225Q21H, N9288CD508, 6NAF1689IO, 6IO182RP7A, IHN2NQ5OF9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0270-22024-11-04C16284748780-1d6a99b3a-01ff-a426-e053-dadaa90af4c2DRUG FACTS:
50845-0270-22024-01-30C16284748780-1d6a99b3a-01ff-a426-e053-dadaa90af4c2DRUG FACTS:
50845-0270-22022-04-20C16284748780-1d6a99b3a-01ff-a426-e053-dadaa90af4c2DRUG FACTS:
50845-0270-22022-01-28C16284748780-1d6a99b3a-01ff-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0270-1Pollen Distress30 mL in 1 BOTTLE, SPRAYSPRAY305
50845-0270-2Pollen Distress1 in 1 CARTONSPRAY15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0270POLLEN DISTRESS (ALLIUM CEPA, APIS MELLIFICA, ARALIA RACEMOSA, ARUNDO MAURITANICA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SABADILLA, SANGUINARIA CANADENSIS, URTICA URENS) SPRAY [LIDDELL LABORATORIES, INC.]4Current NDC, Legacy NDC, 2 package rows20241105_a05f7d34-9f5c-42a4-a9f5-8e62e1e86020.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50845-0270-15084502700130 mL in 1 BOTTLE, SPRAY30 mlHistorical
50845-0270-2508450270021 BOTTLE, SPRAY in 1 CARTON (50845-0270-2) / 30 mL in 1 BOTTLE, SPRAY (50845-0270-1) 2020-12-072027-04-06NoNoCurrent