shoprite ni calm

Product NDC
41190-763
11-digit product format
411900763
Labeler code
41190
Product ID
41190-763_d584ca8e-d9b7-45b4-8cbc-43169b93071b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Wakefern Food Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-09-22
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/30mL; mg/30mL; mg/30mL; mg/30mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct41190-763DDiscontinued by firm2026-10-05
excluded packagepackage41190-76341190-763-40DDiscontinued by firm2026-10-05

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41190-763-40d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41190-763-40f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41190-763-402ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41190-763-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41190-763-40cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41190-763-40cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41190-763-40302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41190-763-40ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41190-763-400efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41190-763-40ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41190-763-40367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41190-763-40557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2SHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLSHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWSHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
SUCROSEINACTIVE INGREDIENTC151H8M554SHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RSHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESHOPRITE NI-CALM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [WAKEFERN FOOD CORPORATION]1