Colic Calm Plus

Product NDC
13992-002
Requested package NDC
13992-002-01
11-digit product format
139920002
Labeler code
13992
Product ID
13992-002_1954c1ef-535f-4764-b1ec-18a0ebc70d8b
Type
HUMAN OTC DRUG
Nonproprietary name
Aloe, Asafoetida, Carbo Vegetabilis, Carum Carvi, Chamomilla, Cinchona Officinalis, Foeniculum Vulgare, Magnesia Phosphorica, Melissa Officinalis, Mentha Piperita, Prunus Spinosa, Zingiber Officinale
Dosage form
LIQUID
Route
ORAL
Labeler
TJL Enterprises Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-12-13
Marketing end
2024-02-11
Substance
ALOE; FERULA ASSA-FOETIDA RESIN; ACTIVATED CHARCOAL; CARAWAY OIL; CHAMOMILE; CINCHONA OFFICINALIS BARK; FENNEL SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MELISSA OFFICINALIS; MENTHA PIPERITA; PRUNUS SPINOSA FLOWER BUD; GINGER
Active strength
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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage13992-00213992-002-01DDiscontinued by firm2026-09-14

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 · 12 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…

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13992-002-01139920002011 BOTTLE, WITH APPLICATOR in 1 CARTON (13992-002-01) > 59 mL in 1 BOTTLE, WITH APPLICATOR2016-12-132024-02-11NoNoCurrent