Home NDC 75920-0465 Gemma Cut the Cramp
Product NDC 75920-0465
11-digit product format 759200465
Labeler code 75920
Product ID 75920-0465_471b4be3-b0d3-b56e-e063-6394a90aaa59
Type HUMAN OTC DRUG
Nonproprietary name Aspirin, Caffeine
Dosage form TABLET, EFFERVESCENT
Route ORAL
Labeler Rally Labs LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-23
Substance ASPIRIN; CAFFEINE
Active strength 500; 60 mg/1000mg; mg/1000mg
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Gemma Cut the Cramp
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASPIRIN 500 mg/1000mg CAFFEINE 60 mg/1000mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R16CO5Y76E Internal UNII lookup 3G6A5W338E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1537019 Internal RxNorm 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 75920-0465-2 Gemma Cut the Cramp 6816 mg in 1 POUCH TABLET, EFFERVESCENT 6816 3 75920-0465-2 Gemma Cut the Cramp 20 in 1 CARTON TABLET, EFFERVESCENT 20 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75920-0465 GEMMA CUT THE CRAMP (ASPIRIN, CAFFEINE) TABLET, EFFERVESCENT [RALLY LABS LLC] 2 Current NDC, 2 package rows 20241218_16c9a296-077a-8e12-e063-6294a90a1b8b.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 85 · 1,681 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 75920-0465-2 75920046502 20 POUCH in 1 CARTON (75920-0465-2) / 6816 mg in 1 POUCH 20 pouch 2024-04-23 No No Current