Home NDC 35484-924-04 Cramp911
Product NDC 35484-924
Requested package NDC 35484-924-04
11-digit product format 354840924
Labeler code 35484
Product ID 35484-924_484de743-f0ee-68fb-e063-6294a90ac352
Type HUMAN OTC DRUG
Nonproprietary name Magnesium sulfate, Copper sulfate
Dosage form LOTION
Route TOPICAL
Labeler DelCorean, LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2008-09-01
Substance BASIC COPPER SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM
Active strength .05; .05 [hp_X]/mL; [hp_X]/mL
Pharmacologic classes Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 35484-924 35484-924-04 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Cramp911
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAGNESIUM SULFATE, UNSPECIFIED FORM .05 [hp_X]/mL BASIC COPPER SULFATE .05 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DE08037SAB Internal UNII lookup CUP529P5NS Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35484-924-04 Cramp911 4.5 mL in 1 BOTTLE, WITH APPLICATOR LOTION 4.5 9 35484-924-04 Cramp911 1 in 1 CARTON LOTION 1 9 35484-924-21 Cramp911 21 mL in 1 BOTTLE, WITH APPLICATOR LOTION 21 9 35484-924-21 Cramp911 1 in 1 CARTON LOTION 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35484-924 CRAMP911 (MAGNESIUM SULFATE, COPPER SULFATE) LOTION [DELCOREAN, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20250112_481f5af0-deb4-5bd3-e054-00144ff8d46c.zip 35484-924 CRAMP911 (MAGNESIUM SULFATE, COPPER SULFATE) LOTION [DELCOREAN, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20250112_47b59658-f4ba-45cb-e054-00144ff88e88.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 35484-924-04 35484092404 1 BOTTLE, WITH APPLICATOR in 1 CARTON (35484-924-04) / 4.5 mL in 1 BOTTLE, WITH APPLICATOR 2008-09-01 0000-00-00 No No Current