FDA.reportPublic FDA data

anti-diarrheal

Product NDC
21130-835
11-digit product format
211300835
Labeler code
21130
Product ID
21130-835_323643aa-2d51-0968-e063-6394a90aba7a
Type
HUMAN OTC DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Albertsons Companies
Application
NDA021855
Marketing category
NDA
Marketing start
2025-04-07
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021855-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04
N021855-002LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04a50c72e98297…
2026-08-01 22:54:322026-06N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
anti-diarrhealLOPERAMIDE HYDROCHLORIDEAmazon.com Services LLC04a35525-ae8e-b41e-e063-6294a90ab10e2026-04-20WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECVS Pharmacy, Inc.60bc8f05-f35e-45e0-ba3b-c82a87d60f5b2026-02-27WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Imodium A-DLOPERAMIDE HYDROCHLORIDEKenvue Brands LLC31bfcbb4-c58c-4edc-ac68-356a448b75072025-12-22WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENS50814751-8bee-4768-bf6c-e9da3400090b2025-12-15WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETARGET Corporationee8a6bdf-847e-4b88-8aea-6d3daa6699942025-12-12WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INC440fb3ce-4106-4169-b187-cfbfdd2f42c12025-12-11WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.35a938af-decf-5b5d-e063-6294a90a9ab02025-05-21WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.35aa2daf-3486-7ee2-e063-6394a90ad4732025-05-21WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
anti-diarrhealLOPERAMIDE HYDROCHLORIDEAlbertsons Companies1d4ec76d-ff0d-a55d-e063-6294a90ae22c2025-04-07WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ndc (product): 21130-835
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDISCOUNT DRUG MART, INC.ed28814d-9733-46ff-930f-b148e31f2f512024-12-23WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEKROGER COMPANYff5dcb48-318c-4f2a-8df2-73ff6dd2a49e2024-12-23WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
anti-diarrhealLOPERAMIDE HYDROCHLORIDEPUBLIX SUPER MARKETS INC17035ff7-8ba8-131c-e063-6394a90af5ea2024-10-03WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECARDINAL HEALTHbd58d6e9-628c-4c6b-b44c-da95e0417ba72024-05-31WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
anti-diarrhealLOPERAMIDE HYDROCHLORIDEBionpharma Inc.a14bd404-cc79-06e0-e053-2a95a90a68412023-12-26WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
anti-diarrhealLOPERAMIDE HYDROCHLORIDEVALU MERCHANDISERS COMPANYfed347ad-cfbb-9ee8-e053-6394a90ad2752023-10-10WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDESTRATEGIC SOURCING SERVICESf9e03d2b-2ec0-322b-e053-6394a90a15992023-04-21WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)c62bc8d4-0857-16fc-e053-2a95a90a0c412022-12-30WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
ANTI-DIARRHEALLOPERAMIDE HYDROCHLORIDENortheast Pharmac2db4155-68d4-71be-e053-2a95a90a7f352022-12-30WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEPremier Value Alliance LLC0dd97bfb-67ce-472f-9b23-15f613bb31352022-12-29WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWal-Mart Stores, Inc.507acd63-b2b4-465e-bb94-2d66724de20a2022-12-29WarningsExact identifier
application applno (NDA): 021855
application number: NDA021855

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
77TI35393CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
978006Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d4ec76d-ff0d-a55d-e063-6294a90ae22cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-835-12anti-diarrheal2 in 1 CARTONCAPSULE, LIQUID FILLED22
21130-835-12anti-diarrheal12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-835ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [ALBERTSONS COMPANIES]2Current NDC, 2 package rows20250409_1d4ec76d-ff0d-a55d-e063-6294a90ae22c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSN1d4ec76d-ff0d-a55d-e063-6294a90ae22c2
978006loperamide hydrochloride 2 MG Oral CapsuleSCD1d4ec76d-ff0d-a55d-e063-6294a90ae22c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-835-12211300835122 BLISTER PACK in 1 CARTON (21130-835-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2025-04-07NoNoCurrent