Sore Throat

Product NDC
57520-0157
11-digit product format
575200157
Labeler code
57520
Product ID
57520-0157_c8b67091-950b-477e-9a6a-268704b521d3
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea purpurea, Plantago major, Baptisia tinctoria
Dosage form
SPRAY
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-06-25
Marketing end
0000-00-00
Substance
ECHINACEA PURPUREA; PLANTAGO MAJOR; BAPTISIA TINCTORIA ROOT; PHYTOLACCA AMERICANA ROOT; APIS MELLIFERA; ATROPA BELLADONNA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; CALCIUM SULFIDE
Active strength
2 [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
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57520-0157IInactivated by FDA2026-10-12
excluded packagepackage57520-015757520-0157-1IInactivated by FDA2026-10-12

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57520-0157-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57520-0157-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57520-0157-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57520-0157-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57520-0157-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57520-0157-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57520-0157-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57520-0157-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57520-0157-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57520-0157-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57520-0157-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57520-0157-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage57520-0157-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage57520-0157-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage57520-0157-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57520-0157-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57520-0157-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57520-0157-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage57520-0157-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage57520-0157-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage57520-0157-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage57520-0157-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-0157-12020-01-31C16284748780-19d75b9cf-ffad-f424-e053-dadaa90a57ceSore Throat Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57520-0157-1Sore Throat30 mL in 1 BOTTLE, SPRAYSPRAY302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43ZSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
BAPTISIA TINCTORIA ROOTACTIVE INGREDIENT5EF0HWI5WUSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51QSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
ECHINACEA PURPUREAACTIVE INGREDIENTQI7G114Y98SORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07ISORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G2SORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEGSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6USORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
APIS MELLIFERAACTIVE MOIETY7S82P3R43ZSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
BAPTISIA TINCTORIA ROOTACTIVE MOIETY5EF0HWI5WUSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
ECHINACEA PURPUREAACTIVE MOIETYQI7G114Y98SORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07ISORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G2SORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEGSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
PLANTAGO MAJORACTIVE MOIETYW2469WNO6USORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
CLOVEINACTIVE INGREDIENTK48IKT5321SORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
GOLDENSEALINACTIVE INGREDIENTZW3Z11D0JVSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ASORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
MYRRHINACTIVE INGREDIENTJC71GJ1F3LSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
SAGEINACTIVE INGREDIENT065C5D077JSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
SPEARMINT OILINACTIVE INGREDIENTC3M81465G5SORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
STEVIA LEAFINACTIVE INGREDIENT6TC6NN0876SORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
THYMEINACTIVE INGREDIENTCW657OBU4NSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RSORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57520-0157SORE THROAT (ECHINACEA PURPUREA, PLANTAGO MAJOR, BAPTISIA TINCTORIA) SPRAY [APOTHECA COMPANY]2Legacy NDC, 1 package rows20100629_5276bc49-c405-4375-b6e5-2d9a7afa95f4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
57520-0157-15752001570130 mL in 1 BOTTLE, SPRAY30 mlHistorical