FDA.reportPublic FDA data

PMS

Product NDC
50845-0109
Requested package NDC
50845-0109-2
11-digit product format
508450109
Labeler code
50845
Product ID
50845-0109_60e20997-4f40-4924-b320-cebb1e6128a9
Type
HUMAN OTC DRUG
Nonproprietary name
Apis Mellifica, Chamomilla, Cimicifuga Racemosa, Cuprum Metallicum, Ignatia Amara, Kali Iodatum, Magnesia Phosphorica, Oophorinum (Suis), Platinum Metallicum, Sepia, Thuja Occidentalis
Dosage form
SPRAY
Route
ORAL
Labeler
Liddell Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2011-07-18
Substance
APIS MELLIFERA; BLACK COHOSH; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA WHOLE; PLATINUM; POTASSIUM IODIDE; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; SUS SCROFA OVARY; THUJA OCCIDENTALIS LEAFY TWIG
Active strength
200; 6; 12; 9; 12; 12; 200; 9; 6; 30; 200 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL
Pharmacologic classes
Allergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-05-28 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…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA200 [hp_C]/mL
MATRICARIA CHAMOMILLA WHOLE6 [hp_X]/mL
BLACK COHOSH12 [hp_X]/mL
COPPER9 [hp_X]/mL
STRYCHNOS IGNATII SEED12 [hp_X]/mL
POTASSIUM IODIDE12 [hp_X]/mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE200 [hp_C]/mL
SUS SCROFA OVARY9 [hp_X]/mL
PLATINUM6 [hp_X]/mL
SEPIA OFFICINALIS JUICE30 [hp_C]/mL
THUJA OCCIDENTALIS LEAFY TWIG200 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7S82P3R43ZInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
K73E24S6X9Internal UNII lookup
789U1901C5Internal UNII lookup
1NM3M2487KInternal UNII lookup
1C4QK22F9JInternal UNII lookup
HF539G9L3QInternal UNII lookup
S7YTV04R8OInternal UNII lookup
49DFR088MYInternal UNII lookup
QDL83WN8C2Internal UNII lookup
1NT28V9397Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
575b4736-5bae-4f15-b55b-3e1fbbb613ffAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-07-01DRUG FACTS:
2024-01-30DRUG FACTS:
2022-04-20DRUG FACTS:
2021-01-29DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0109-1PMS30 mL in 1 BOTTLE, SPRAYSPRAY309
50845-0109-2PMS1 in 1 CARTONSPRAY19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43ZPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
BLACK COHOSHACTIVE INGREDIENTK73E24S6X9PMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
COPPERACTIVE INGREDIENT789U1901C5PMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEACTIVE INGREDIENTHF539G9L3QPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
PLATINUMACTIVE INGREDIENT49DFR088MYPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9JPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C2PMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487KPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
SUS SCROFA OVARYACTIVE INGREDIENTS7YTV04R8OPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V9397PMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
APIS MELLIFERAACTIVE MOIETY7S82P3R43ZPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
BLACK COHOSHACTIVE MOIETYK73E24S6X9PMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
COPPERACTIVE MOIETY789U1901C5PMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
IODIDE IONACTIVE MOIETY09G4I6V86QPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838PMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
PLATINUMACTIVE MOIETY49DFR088MYPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C2PMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487KPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
SUS SCROFA OVARYACTIVE MOIETYS7YTV04R8OPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V9397PMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RPMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM, PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS,) SPRAY [LIDDELL LABORATORIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0109PMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM (SUIS), PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS) SPRAY [LIDDELL LABORATORIES, INC.]9Current NDC, Legacy NDC, 2 package rows20240702_575b4736-5bae-4f15-b55b-3e1fbbb613ff.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
PMSAPIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM (SUIS), PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.575b4736-5bae-4f15-b55b-3e1fbbb613ff2024-07-01WarningsExact identifier
ndc (package): 50845-0109-2
ndc (product): 50845-0109
ndc11 (package): 50845010902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50845-0109-2508450109021 BOTTLE, SPRAY in 1 CARTON (50845-0109-2) / 30 mL in 1 BOTTLE, SPRAY (50845-0109-1) 2016-09-060000-00-00NoNoCurrent