FDA.reportPublic FDA data

Immune Forte

Product NDC
43857-0166
Requested package NDC
43857-0166-1
11-digit product format
438570166
Labeler code
43857
Product ID
43857-0166_cabc3e38-84d4-4daa-9121-9ad42ad17b21
Type
HUMAN OTC DRUG
Nonproprietary name
Dehydroepiandrosterone (DHEA), Estradiol, Hypophysis Suis, Pregnenolone, Progesterone, Spleen (Bovine), Testosterone, Thymus (Suis), Thyroidinum (Suis)
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-08-07
Substance
PRASTERONE; ESTRADIOL; SUS SCROFA PITUITARY GLAND; PREGNENOLONE; PROGESTERONE; BOS TAURUS SPLEEN; TESTOSTERONE; SUS SCROFA THYMUS; THYROID
Active strength
8; 8; 8; 8; 8; 8; 8; 8; 8 [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
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Immune Forte
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRASTERONE8 [hp_X]/mL
ESTRADIOL8 [hp_X]/mL
SUS SCROFA PITUITARY GLAND8 [hp_X]/mL
PREGNENOLONE8 [hp_X]/mL
PROGESTERONE8 [hp_X]/mL
BOS TAURUS SPLEEN8 [hp_X]/mL
TESTOSTERONE8 [hp_X]/mL
SUS SCROFA THYMUS8 [hp_X]/mL
THYROID8 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
459AG36T1BInternal UNII lookup
4TI98Z838EInternal UNII lookup
L0PFEMQ1DTInternal UNII lookup
73R90F7MQ8Internal UNII lookup
4G7DS2Q64YInternal UNII lookup
190Q9MB3U3Internal UNII lookup
3XMK78S47OInternal UNII lookup
7B69B0BD62Internal UNII lookup
6RV024OAUQInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c355245-260a-464b-abcf-95416b49caa3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
2db4fc38-a116-b0ab-3dae-57df54e5f212Product name220250121
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
386d1b2a-e9b7-0c83-111f-2a77b92895b3Product name520240422
7d55b53c-798b-47ae-992b-3921493a8303Product name120230322
8d753fd6-75b2-4f12-bcbf-339392960afaProduct name120230303
4fbda828-a5be-46fe-83ec-a88da4359919Product name120230104
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
09e1afd3-f431-4380-82c5-438884c25615Product name120190111
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
a6389cd1-36d1-4b5c-9934-1139bee93605Product name320171212
502efed8-01a5-ef6a-61c6-fe8302b6e26bProduct name220171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2Product name120171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68Product name220171113
86ca2ee7-106a-420e-9137-a9ec1af5dbc1Product name120170110
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-08-29DRUG FACTS:
2024-01-30DRUG FACTS:
2022-01-22DRUG FACTS:
2020-01-31DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0166-1Immune Forte30 mL in 1 BOTTLE, SPRAYLIQUID306

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BOS TAURUS SPLEENACTIVE INGREDIENT190Q9MB3U3IMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ESTRADIOLACTIVE INGREDIENT4TI98Z838EIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PRASTERONEACTIVE INGREDIENT459AG36T1BIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PREGNENOLONEACTIVE INGREDIENT73R90F7MQ8IMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SUS SCROFA PITUITARY GLANDACTIVE INGREDIENTE8S87O660TIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SUS SCROFA THYMUSACTIVE INGREDIENT7B69B0BD62IMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
THYROID, PORCINEACTIVE INGREDIENT6RV024OAUQIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
BOS TAURUS SPLEENACTIVE MOIETY190Q9MB3U3IMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
ESTRADIOLACTIVE MOIETY4TI98Z838EIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PRASTERONEACTIVE MOIETY459AG36T1BIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
PREGNENOLONEACTIVE MOIETY73R90F7MQ8IMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SUS SCROFA PITUITARY GLANDACTIVE MOIETYE8S87O660TIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SUS SCROFA THYMUSACTIVE MOIETY7B69B0BD62IMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SUS SCROFA THYROIDACTIVE MOIETY6RV024OAUQIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
TESTOSTERONEACTIVE MOIETY3XMK78S47OIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RIMMUNE FORTE (DEHYDRO-EPI-ANDROSTERONE (DHEA), ESTRADIOL, PITUITARY (SUIS), PREGNOENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0166IMMUNE FORTE (DEHYDROEPIANDROSTERONE (DHEA), ESTRADIOL, HYPOPHYSIS SUIS, PREGNENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]6Current NDC, Legacy NDC, 1 package rows20240830_9c355245-260a-464b-abcf-95416b49caa3.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
Immune ForteDEHYDROEPIANDROSTERONE (DHEA), ESTRADIOL, HYPOPHYSIS SUIS, PREGNENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)BioActive Nutritional, Inc.9c355245-260a-464b-abcf-95416b49caa32024-08-29WarningsExact identifier
ndc (package): 43857-0166-1
ndc (product): 43857-0166
ndc11 (package): 43857016601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0166-14385701660130 mL in 1 BOTTLE, SPRAY (43857-0166-1) 30 ml2016-12-020000-00-00NoNoCurrent