FDA.reportPublic FDA data

Aluminum Hydroxide

Product NDC
17856-0091
11-digit product format
178560091
Labeler code
17856
Product ID
17856-0091_4602216a-bb8c-af52-e063-6294a90a380e
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide
Dosage form
LIQUID
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-02-01
Substance
ALUMINUM HYDROXIDE
Active strength
320 mg/5mL
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct17856-0091IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-009117856-0091-3IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE320 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5QB0T2IUN0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308078Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
60a54d4e-89c2-4329-86bf-a288527f37b5Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0091-32024-04-16C16284748780-1f386c649-ab6b-0266-e053-dadaa90a7c1a60a54d4e-89c2-4329-86bf-a288527f37b5
17856-0091-32023-01-30C16284748780-1f386c649-ab6b-0266-e053-dadaa90a7c1a60a54d4e-89c2-4329-86bf-a288527f37b5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0091-3Aluminum Hydroxide30 mL in 1 CUPLIQUID307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0091-3ML - Milliliter17856-0091f51e697f-15bd-42dc-a54e-21759b65d2f412020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0091ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) LIQUID [ATLANTIC BIOLOGICALS CORP.]6Current NDC, Legacy NDC, 1 package rows20250514_60a54d4e-89c2-4329-86bf-a288527f37b5.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 5 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Pain Relieving Cream with Menthol 10%MENTHOL 10% CREAMONE2ZEE LIMITED LIABILITY COMPANYae09e93f-3988-4477-ae53-b2f3df9769fb2025-05-05WarningsExact identifier
application number: M
Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.edf07b7f-46fb-4915-b2ea-83d852617f602025-04-10WarningsExact identifier
application number: M
BRONCOCHEM KIDS COLD AND FLUACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb6559fb9-2dea-49c0-a274-3e77741a0ffd2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLdeecdb72-4cdb-4d6f-972f-a425a91afa5a2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLdffdfa2c-a52e-4606-9b07-c8993e499f092025-03-23WarningsExact identifier
application number: M
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRL1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH KIDSDEXTROMETHORPHAN HBR-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb0fd2f2f-5cc4-4813-8f99-c78fbe8986562025-03-13WarningsExact identifier
application number: M
Menthol Pain Relief Gel PatchMENTHOL PAIN RELIEF GEL PATCHONE2ZEE LIMITED LIABILITY COMPANYeab185d6-2a54-489d-8114-fe8088624ba42025-03-04WarningsExact identifier
application number: M
Lidocaine 4% Pain Relief Gel PatchLIDOCAINE 4% PAIN RELIEF GEL PATCHONE2ZEE LIMITED LIABILITY COMPANY8e5a4ef4-b928-44b3-842c-92f1531af75b2025-03-03WarningsExact identifier
application number: M
gas reliefSIMETHICONEStrategic Sourcing Services LLC23005295-c5f2-4a76-8431-4a9b8d817d4d2025-01-03WarningsExact identifier
application number: M
Foster and Thrive infants Gas reliefSIMETHICONEStrategic Sourcing Services LLC824c9dff-0a26-4710-a25b-39df631d6fa62024-12-13WarningsExact identifier
application number: M
BRONCOCHEM COLD AND FLU TEAACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLb7d3f54e-59ef-4b85-a88d-b053058dc1f62024-12-12WarningsExact identifier
application number: M
HYSAN PAIN RELIEVERMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDbad73234-c204-40a8-8176-45c75ae500c82024-10-07WarningsExact identifier
application number: M
HYSAN ANALGESICMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTD99a13b0a-1d77-479e-ba99-2cfa638de3392024-10-04WarningsExact identifier
application number: M
HYSAN HUO LU MEDICATEDMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDfe9eeaff-fcbf-4287-9f17-bcf1822bf35b2024-10-04WarningsExact identifier
application number: M
HYSAN HUA TUO MEDICATEDMETHYL SALICYLATEHYSAN PHARMACEUTICAL CO LTDb84c4d33-5a77-46e0-b04e-32f73967bd1c2024-10-04WarningsExact identifier
application number: M
HYSAN HUA TUO HUO LUMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDcd2288c4-9909-43c1-91da-b15545b097882024-10-04WarningsExact identifier
application number: M
CLARINS - ROLL-ON DEODORANT Aluminum Chlorohydrate - Antiperspirant, Long-lasting Alcohol-freeALUMINUM CHLOROHYDRATELaboratoires Clarins412116a1-f9af-4c03-85e0-aad5738dd7972024-08-05WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRL1a3ed214-e09b-4266-b68b-39e7c3127d262024-04-22WarningsExact identifier
application number: M
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions835c3c23-fc3c-404e-8e87-5a01761267302024-02-28WarningsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308078aluminum hydroxide 320 MG in 5 mL Oral SuspensionPSN60a54d4e-89c2-4329-86bf-a288527f37b57
308078aluminum hydroxide 64 MG/ML Oral SuspensionSCD60a54d4e-89c2-4329-86bf-a288527f37b57
308078aluminum hydroxide 320 MG per 5 ML Oral SuspensionSY60a54d4e-89c2-4329-86bf-a288527f37b57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0091-31785600910330 mL in 1 CUP (17856-0091-3) 30 ml2024-04-160000-00-00NoNoCurrent