FDA.reportPublic FDA data

Spascupreel

Product NDC
50114-6129
11-digit product format
501146129
Labeler code
50114
Product ID
50114-6129_eab7b089-635c-472d-a952-8ad4f063ae0c
Type
HUMAN OTC DRUG
Nonproprietary name
ACONITUM NAPELLUS and AMMONIUM BROMIDE and CITRULLUS COLOCYNTHIS FRUIT PULP and ATROPINE SULFATE and GELSEMIUM SEMPERVIRENS ROOT and MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE and VERATRUM ALBUM ROOT and PASSIFLORA INCARNATA FLOWERING TOP and MATRICARIA RECUTITA and AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY and CUPRIC SULFATE
Dosage form
SOLUTION
Route
ORAL
Labeler
Heel Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1993-01-31
Marketing end
0000-00-00
Substance
ACONITUM NAPELLUS; AMMONIUM BROMIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; ATROPINE SULFATE; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; VERATRUM ALBUM ROOT; PASSIFLORA INCARNATA FLOWERING TOP; MATRICARIA RECUTITA; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; CUPRIC SULFATE
Active strength
6 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50114-6129-62019-11-13C16284748780-197449f38-c89c-f6ea-e053-dbdaa90aa703Spascupreel 1.1ml Oral Vial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50114-6129-6Spascupreel1.1 mL in 1 VIALSOLUTION1.11
50114-6129-6Spascupreel10 in 1 CARTONSOLUTION101

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODYACTIVE INGREDIENTDIF093I037SPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
AMMONIUM BROMIDEACTIVE INGREDIENTR0JB3224WSSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5SPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE INGREDIENT23H32AOH17SPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
CUPRIC SULFATEACTIVE INGREDIENTLRX7AJ16DTSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1QSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEACTIVE INGREDIENTHF539G9L3QSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11OSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
VERATRUM ALBUM ROOTACTIVE INGREDIENTQNS6W5US1ZSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODYACTIVE MOIETYDIF093I037SPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
AMMONIUM BROMIDEACTIVE MOIETYR0JB3224WSSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE MOIETY23H32AOH17SPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1QSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11OSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
SULFATE IONACTIVE MOIETY7IS9N8KPMGSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
VERATRUM ALBUM ROOTACTIVE MOIETYQNS6W5US1ZSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50114-6129SPASCUPREEL (ACONITUM NAPELLUS AND AMMONIUM BROMIDE AND CITRULLUS COLOCYNTHIS FRUIT PULP AND ATROPINE SULFATE AND GELSEMIUM SEMPERVIRENS ROOT AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE AND VERATRUM ALBUM ROOT AND PASSIFLORA INCARNATA FLOWERING TOP AND MATRICARIA RECUTITA AND AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY AND CUPRIC SULFATE) SOLUTION [HEEL INC]1Legacy NDC, 2 package rows20120510_93bd169a-7456-431d-8224-9194911058c6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50114-6129-6501146129061.1 mL in 1 VIAL1.1 mlHistorical