FDA.reportPublic FDA data

Astringent

Product NDC
63561-0178
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

Additional Listing Data#

Finished product
Yes
Brand name base
Astringent
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM SULFATE TETRADECAHYDRATE1347 mg/2299mg
CALCIUM ACETATE MONOHYDRATE952 mg/2299mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE3UT66504P, 7ZA48GIM5H
Rxcui1250234

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63561-0178-22025-02-21C16284748780-12cef2736-5d12-d83d-e063-dadaa90ab31fAstringent Solution
63561-0178-22025-01-30C16284748780-12cef2736-5d12-d83d-e063-dadaa90ab31fAstringent Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63561-0178-1Astringent2299 mg in 1 PACKETPOWDER, FOR SOLUTION22993
63561-0178-2Astringent12 in 1 CARTONPOWDER, FOR SOLUTION123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63561-0178ASTRINGENT (CALCIUM ACETATE MONOHYDRATE AND ALUMINUM SULFATE TETRADECAHYDRATE) POWDER, FOR SOLUTION [GRANULATION TECHNOLOGY, INC.]2Current NDC, 2 package rows20250223_1c2bf19c-2f32-4a22-a371-16cc744dce76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250234aluminum sulfate 1347 MG / calcium acetate 952 MG in 160 ML Topical SolutionPSN1c2bf19c-2f32-4a22-a371-16cc744dce763
1250234aluminum sulfate 8.42 MG/ML / calcium acetate 5.95 MG/ML Topical SolutionSCD1c2bf19c-2f32-4a22-a371-16cc744dce763
1250234(3 Packets (aluminum sulfate 1347 MG Powder / calcium acetate 952 MG Powder)) per 16 OZ Topical SolutionSY1c2bf19c-2f32-4a22-a371-16cc744dce763
1250234aluminum sulfate 1347 MG / calcium acetate 952 MG per 160 ML Topical SolutionSY1c2bf19c-2f32-4a22-a371-16cc744dce763

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63561-0178-1635610178012299 mg in 1 PACKET2299 mgHistorical
63561-0178-26356101780212 PACKET in 1 CARTON (63561-0178-2) / 2299 mg in 1 PACKET (63561-0178-1) 12 packet2025-06-12NoNoCurrent