COUGH AND COLD RELIEF

Product NDC
60512-0013
Requested package NDC
60512-0013-1
11-digit product format
605120013
Labeler code
60512
Product ID
60512-0013_9cbf8163-0862-14d4-e053-2995a90a06d1
Type
HUMAN OTC DRUG
Nonproprietary name
DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS
Dosage form
PELLET
Route
ORAL
Labeler
HOMEOLAB USA INC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-10-18
Marketing end
0000-00-00
Substance
DROSERA ROTUNDIFOLIA; ARSENIC TRIOXIDE; IPECAC; POTASSIUM DICHROMATE; ATROPA BELLADONNA WHOLE; PULSATILLA VULGARIS; MERCURIUS SOLUBILIS
Active strength
3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60512-001360512-0013-1DDiscontinued by firm2026-10-20

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60512-0013-12025-12-28C16284748780-1d6a99b39-866e-a426-e053-dadaa90af4c2DRUG FACTS
60512-0013-12022-01-28C16284748780-1d6a99b39-866e-a426-e053-dadaa90af4c2DRUG FACTS

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HOCOUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
ATROPA BELLADONNA WHOLEACTIVE INGREDIENTDSV74G1P2JCOUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
DROSERA ROTUNDIFOLIAACTIVE INGREDIENTQR44N9XPJQCOUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
IPECACACTIVE INGREDIENT62I3C8233LCOUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G2COUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FMCOUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVCOUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AVCOUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
ATROPA BELLADONNA WHOLEACTIVE MOIETYDSV74G1P2JCOUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
DICHROMATE IONACTIVE MOIETY9LKY4BFN2VCOUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
DROSERA ROTUNDIFOLIAACTIVE MOIETYQR44N9XPJQCOUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
IPECACACTIVE MOIETY62I3C8233LCOUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G2COUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVCOUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCOUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554COUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60512-0013COUGH AND COLD RELIEF (DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS) PELLET [HOMEOLAB USA INC.]4Legacy NDC20200123_f784b3ae-b803-4da6-b08b-2acabf60ce5b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60512-0013-16051200130180 PELLET in 1 TUBE (60512-0013-1) 80 pellet2013-10-180000-00-00NoNoCurrent