Home NDC 63561-0178-2 Astringent
Product NDC 63561-0178
Requested package NDC 63561-0178-2
11-digit product format 635610178
Labeler code 63561
Product ID 63561-0178_37553cf5-a897-fef9-e063-6394a90a7812
Type HUMAN OTC DRUG
Nonproprietary name Calcium acetate monohydrate and Aluminum sulfate tetradecahydrate
Dosage form POWDER, FOR SOLUTION
Route TOPICAL
Labeler Granulation Technology, Inc.
Application part347
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-12
Substance ALUMINUM SULFATE TETRADECAHYDRATE; CALCIUM ACETATE MONOHYDRATE
Active strength 1347; 952 mg/2299mg; mg/2299mg
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 3 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 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63561-0178 63561-0178-2 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63561-0178 63561-0178-2 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63561-0178 63561-0178-2 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Astringent
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM ACETATE MONOHYDRATE 1347 mg/2299mg ALUMINUM SULFATE TETRADECAHYDRATE 952 mg/2299mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7ZA48GIM5H Internal UNII lookup E3UT66504P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1250234 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63561-0178-1 Astringent 2299 mg in 1 PACKET POWDER, FOR SOLUTION 2299 3 63561-0178-2 Astringent 12 in 1 CARTON POWDER, FOR SOLUTION 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63561-0178 ASTRINGENT (CALCIUM ACETATE MONOHYDRATE AND ALUMINUM SULFATE TETRADECAHYDRATE) POWDER, FOR SOLUTION [GRANULATION TECHNOLOGY, INC.] 2 Current NDC, 2 package rows 20250223_1c2bf19c-2f32-4a22-a371-16cc744dce76.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 · 1 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 63561-0178-2 63561017802 12 PACKET in 1 CARTON (63561-0178-2) / 2299 mg in 1 PACKET (63561-0178-1) 12 packet 2025-06-12 No No Current