FDA.reportPublic FDA data

topcare dual action complete

Product NDC
36800-082
11-digit product format
368000082
Labeler code
36800
Product ID
36800-082_8ff82275-ff8b-4073-ab1d-5f802e0c21a4
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine, Calcium Carbonate, Magnesium Hydroxide
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA077355
Marketing category
ANDA
Marketing start
2016-02-29
Substance
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
Active strength
800; 10; 165 mg/1; mg/1; mg/1
Pharmacologic classes
Calculi Dissolution Agent [EPC], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-08236800-082-71DDiscontinued by firm2026-07-31

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDECALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06

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 22:54:322026-06A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06a50c72e98297…

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 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DUAL ACTION COMPLETEFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmazon.com Services LLC4e8a936c-b876-4923-ad9e-d23537b5d7cf2026-07-28WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
COMPLETE ACID REDUCERFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED962ced24-0fb3-4aba-b32e-2e6fa1c1c5d72026-07-22WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
Good Neighbor Pharmacy Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmerisource Bergenb7453c0e-b452-409b-a324-83fdd105bfd02026-06-02WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEMeijer Distribution Inc50fe57e1-6678-4697-9b35-4673db67d4fb2026-06-01WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
COMPLETE ACID REDUCERFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED6ccc03bd-3f36-452a-8945-b3d71cce82412026-04-08WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
Acid Reducer Plus AntacidFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDERite Aid Corporation5490abe2-11f0-45a8-aefa-f70263ff1da82026-03-27WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
GOOD SENSE DUAL ACTION COMPLETEFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEL. Perrigo Companyb5a36da3-7316-493c-b50f-fc5393d858c02026-03-24WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
ACID REDUCER COMPLETEFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWalgreen Companyb94b16d3-b52f-4d70-bbb0-d9fb074c891c2026-03-19WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
complete dual actionFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEHyVee Inc237efe92-b302-4e11-93fe-7b0f727a00aa2026-03-12WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWalgreen Company6f1dcfda-c12a-4c3b-80a2-c9e15517c88f2026-03-03WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEMeijer Distribution Inc6e8ed233-9ffb-46f7-9632-d5bc3d3a558b2026-01-20WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
equaline complete dual actionFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEUnited Natural Foods, Inc. dba UNFIc32cb5be-e1f8-4510-8685-5e03a7d4224c2026-01-13WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
Good Sense Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEL. Perrigo Companyb7154648-8c8c-4ce6-88b7-5442a16143c52025-11-14WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
acid reducer completeFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDESafeway4f0a178c-d0ed-4bbc-a8ce-fda3789d25f02025-10-14WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
Up and Up Dual Action Acid Reducer and AntacidFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDETarget Corporation2f020677-77a0-4e13-9397-e9deeda632932025-09-10WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
topcare dual action completeFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDETopco Associates LLC2c5a1694-d6e9-4679-b421-61eaad5403a42025-09-04WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
ndc (product): 36800-082
CareOne Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmerican Sales Company5d4bea42-25d5-4943-b5ed-471eccd36bf82025-08-29WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
CareOne Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEAmerican Sales Company19045840-2d25-43af-8c92-f36c8b903b282025-08-28WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
ACID REDUCER COMPLETEFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDESafeway484ad323-82cf-4157-bacb-236af8210c872025-08-27WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355
dual action completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEPublix Super Markets Inc913073fe-22ce-40a3-ad22-bf3027c21e992025-08-14WarningsExact identifier
application applno (ANDA): 077355
application number: ANDA077355

Additional Listing Data#

Finished product
Yes
Brand name base
topcare dual action complete
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE800 mg/1
CALCIUM CARBONATE10 mg/1
MAGNESIUM HYDROXIDE165 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5QZO15J2Z8Internal UNII lookup
H0G9379FGKInternal UNII lookup
NBZ3QY004SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283641Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c5a1694-d6e9-4679-b421-61eaad5403a4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
95250459-30e4-45c1-b08a-993044f49109Product name220250805
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-082-632021-11-12C16284748780-1c7ccaba7-255c-fd44-e053-dadaa90aa01bTopco Associates LLC. Dual Action Complete Drug Facts
36800-082-712021-11-12C16284748780-1c7ccaba7-255c-fd44-e053-dadaa90aa01bTopco Associates LLC. Dual Action Complete Drug Facts
36800-082-632021-07-23C16284748780-1c7ccaba7-255c-fd44-e053-dadaa90aa01bTopco Associates LLC. Dual Action Complete Drug Facts
36800-082-712021-07-23C16284748780-1c7ccaba7-255c-fd44-e053-dadaa90aa01bTopco Associates LLC. Dual Action Complete Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-082-63topcare dual action complete25 in 1 BOTTLETABLET, CHEWABLE256
36800-082-71topcare dual action complete50 in 1 BOTTLETABLET, CHEWABLE506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-082TOPCARE DUAL ACTION COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 2 package rows20220721_2c5a1694-d6e9-4679-b421-61eaad5403a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283641famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable TabletPSN2c5a1694-d6e9-4679-b421-61eaad5403a46
283641calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable TabletSCD2c5a1694-d6e9-4679-b421-61eaad5403a46
283641calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable TabletSY2c5a1694-d6e9-4679-b421-61eaad5403a46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-082-633680000826325 TABLET, CHEWABLE in 1 BOTTLE (36800-082-63) 2016-02-290000-00-00NoNoCurrent
36800-082-713680000827150 TABLET, CHEWABLE in 1 BOTTLE (36800-082-71) 2016-02-290000-00-00NoNoCurrent