Immu-n Waker

Product NDC
55714-2596
11-digit product format
557142596
Labeler code
55714
Product ID
55714-2596_35a8382c-d671-ab9a-e063-6394a90acf05
Type
HUMAN OTC DRUG
Nonproprietary name
Apis mel, Echinacea, Hydrastis, Thuja occ, Aconitum nap, Agaricus musc, Allium sat, Aloe, Arnica, Arsenicum alb, Baptisia, Belladonna, Bryonia, Calc carb, Calendula, Capsicum, Carduus mar, Hepar sulph calc, Iodium, Lachesis, Lycopodium, Mercurius viv, Nux vom, Phos, Pulsatilla, Rhus tox, Salvia, Selenium, Taraxacum, Tarentula hisp, Zinc met, Zingiber, Anthracinum, Azadirachta, Influenzinum
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-05-21
Substance
ACONITUM NAPELLUS; ALOE; AMANITA MUSCARIA FRUITING BODY; ANEMONE PULSATILLA; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; AZADIRACHTA INDICA BARK; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; ECHINACEA, UNSPECIFIED; GARLIC; GINGER; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; MERCURY; MILK THISTLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SAGE; SELENIUM; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC
Active strength
15; 15; 15; 15; 6; 15; 15; 15; 16; 16; 15; 15; 15; 15; 15; 6; 15; 15; 6; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Immu-n Waker
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELENIUM15 [hp_X]/mL
TARAXACUM OFFICINALE15 [hp_X]/mL
LYCOSA TARANTULA15 [hp_X]/mL
ZINC15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF6 [hp_X]/mL
ACONITUM NAPELLUS15 [hp_X]/mL
INFLUENZA A VIRUS15 [hp_X]/mL
APIS MELLIFERA15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE16 [hp_X]/mL
GOLDENSEAL16 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG15 [hp_X]/mL
AMANITA MUSCARIA FRUITING BODY15 [hp_X]/mL
GARLIC15 [hp_X]/mL
ALOE15 [hp_X]/mL
ARNICA MONTANA15 [hp_X]/mL
ARSENIC TRIOXIDE6 [hp_X]/mL
BAPTISIA TINCTORIA ROOT15 [hp_X]/mL
ATROPA BELLADONNA15 [hp_X]/mL
BRYONIA ALBA ROOT6 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP30 [hp_X]/mL
CAPSICUM15 [hp_X]/mL
MILK THISTLE15 [hp_X]/mL
CALCIUM SULFIDE15 [hp_X]/mL
IODINE15 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
ECHINACEA, UNSPECIFIED15 [hp_X]/mL
SAGE15 [hp_X]/mL
INFLUENZA B VIRUS15 [hp_X]/mL
ANEMONE PULSATILLA15 [hp_X]/mL
AZADIRACHTA INDICA BARK15 [hp_X]/mL
MERCURY15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
GINGER6 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 36 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H6241UJ22BInternal UNII lookup
39981FM375Internal UNII lookup
86M454L2TTInternal UNII lookup
J41CSQ7QDSInternal UNII lookup
6IO182RP7AInternal UNII lookup
U0NQ8555JDInternal UNII lookup
R9HH0NDE2EInternal UNII lookup
7S82P3R43ZInternal UNII lookup
C88X29Y479Internal UNII lookup
ZW3Z11D0JVInternal UNII lookup
1NT28V9397Internal UNII lookup
DIF093I037Internal UNII lookup
V1V998DC17Internal UNII lookup
V5VD430YW9Internal UNII lookup
O80TY208ZWInternal UNII lookup
S7V92P67HOInternal UNII lookup
5EF0HWI5WUInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
T7J046YI2BInternal UNII lookup
2E32821G6IInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
35a8381a-7fed-ab93-e063-6394a90ae3d7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2596-1Immu-n Waker30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2596IMMU-N WAKER (APIS MEL, ECHINACEA, HYDRASTIS, THUJA OCC, ACONITUM NAP, AGARICUS MUSC, ALLIUM SAT, ALOE, ARNICA, ARSENICUM ALB, BAPTISIA, BELLADONNA, BRYONIA, CALC CARB, CALENDULA, CAPSICUM, CARDUUS MAR, HEPAR SULPH CALC, IODIUM, LACHESIS, LYCOPODIUM, MERCURIUS VIV, NUX VOM, PHOS, PULSATILLA, RHUS TOX, SALVIA, SELENIUM, TARAXACUM, TARENTULA HISP, ZINC MET, ZINGIBER, ANTHRACINUM, AZADIRACHTA, INFLUENZINUM) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20250523_35a8381a-7fed-ab93-e063-6394a90ae3d7.zip

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
Immu-n WakerAPIS MEL, ECHINACEA, HYDRASTIS, THUJA OCC, ACONITUM NAP, AGARICUS MUSC, ALLIUM SAT, ALOE, ARNICA, ARSENICUM ALB, BAPTISIA, BELLADONNA, BRYONIA, CALC CARB, CALENDULA, CAPSICUM, CARDUUS MAR, HEPAR SULPH CALC, IODIUM, LACHESIS, LYCOPODIUM, MERCURIUS VIV, NUX VOM, PHOS, PULSATILLA, RHUS TOX, SALVIA, SELENIUM, TARAXACUM, TARENTULA HISP, ZINC MET, ZINGIBER, ANTHRACINUM, AZADIRACHTA, INFLUENZINUMNewton Laboratories, Inc.35a8381a-7fed-ab93-e063-6394a90ae3d72025-05-21WarningsExact identifier
ndc (product): 55714-2596

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55714-2596-15571425960130 mL in 1 BOTTLE, GLASS (55714-2596-1) 30 ml2025-05-21NoNoCurrent