FDA.reportPublic FDA data

Diphen

Product NDC
82652-021
Requested package NDC
82652-021-01
11-digit product format
826520021
Labeler code
82652
Product ID
82652-021_7e3354b4-6202-423f-bb85-88c0ac01958d
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine, Benzalkonium chloride, Lidocaine hydrochloride, Hydrocortisone, Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, Calcium Carbonate, Ibuprofen, Loratadine, Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride, Potassium Chloride, Magnesium Oxide, Meclizine Hydrochloride, and Bismuth Subsalicylate
Dosage form
KIT
Labeler
Remedy Pack LLC
Application
ANDA076134
Marketing category
ANDA
Marketing start
2022-05-10
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82652-02182652-021-01IInactivated by FDA2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076134-001LORATADINELORATADINE10MGTABLET / ORAL2003-08-18

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-1884e616aacf4f…
2026-08-18 06:07:402026-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076134-001LORATADINE10MGTABLET / ORAL2003-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076134-001LORATADINE10MGTABLET / ORAL2003-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076134-001LORATADINE10MGTABLET / ORAL2003-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076134-001LORATADINE10MGTABLET / ORAL2003-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-183f01610625f2…
2019-09-15 20:21 UTC2019-09A076134-001LORATADINE10MGTABLET / ORAL2003-08-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076134-001LORATADINE10MGTABLET / ORAL2003-08-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076134-001LORATADINE10MGTABLET / ORAL2003-08-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076134-001LORATADINE10MGTABLET / ORAL2003-08-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076134-001LORATADINE10MGTABLET / ORAL2003-08-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076134-001LORATADINE10MGTABLET / ORAL2003-08-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A076134-001LORATADINE10MGTABLET / ORAL2003-08-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A076134-001LORATADINE10MGTABLET / ORAL2003-08-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076134-001LORATADINE10MGTABLET / ORAL2003-08-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076134-001LORATADINE10MGTABLET / ORAL2003-08-18f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
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0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
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2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82652-021-012025-01-30C16284748780-12cef2736-8a1c-d83d-e063-dadaa90ab31fDiphen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82652-021-01Diphen1 in 1 CARTONKIT11
82652-022-01Diphen1 in 1 PACKETTABLET, FILM COATED410 mg1
82652-023-01Diphen2 in 1 PACKETTABLET, CHEWABLE4420 mg1
82652-024-01Diphen2 in 1 PACKETTABLET, FILM COATED8200 mg1
82652-025-01Diphen2 in 1 PACKETTABLET, FILM COATED8500 mg1
82652-026-01Diphen2 in 1 PACKETTABLET, CHEWABLE6262 mg1
82652-027-01Diphen0.9 g in 1 PACKETCREAM3.6 g10 mg in 1g1
82652-029-01Diphen0.9 g in 1 PACKETCREAM1.8 g1.3 mg in 1g1
82652-030-01Diphen2 in 1 PACKETTABLET625 mg1
82652-031-01Diphen1 in 1 PACKETTABLET, FILM COATED425 mg1
82652-032-01Diphen2 in 1 PACKETTABLET85 mg1
82652-033-01Diphen0.75 g in 1 PACKETLIQUID3 g200 mg in 1g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82652-021DIPHEN (BENZOCAINE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, CALCIUM CARBONATE, IBUPROFEN, LORATADINE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM OXIDE, MECLIZINE HYDROCHLORIDE, AND BISMUTH SUBSALICYLATE) KIT [REMEDY PACK LLC]1Legacy NDC, 12 package rows20220717_5d185f23-8af6-4e36-b514-5662986520a5.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINECardinal Health 107, LLC64489b01-a4a7-4c6d-ac84-1dfbd1388d842026-06-04WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
MEDIQUE LoradamedLORATADINESportpharm LLCd6bf0e68-f87c-49ee-a15d-df7f5bfa62212026-04-24WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEPD-Rx Pharmaceuticals, Inc.7127b39d-3686-4249-b720-43c02b4c46542026-03-19WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEA-S Medication Solutionsa53e5635-8633-4c28-b04f-cdfb3d851e682026-02-19WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Green Guard 24 Hour Allergy ReliefLORATADINEUnifirst First Aid Corporation32092beb-c177-4b6b-afa4-b4b5d64621f42025-11-21WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEMarlex Pharmaceuticals, Inc.ec08a6ee-3d71-0fa9-e053-2995a90a9cb12025-11-18WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
McKesson LoratadineLORATADINE 10 MGMcKesson Medical Surgicalc6a3056e-792e-52a4-e053-2a95a90a83612025-10-23WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEAsclemed USA, Inc.332bda00-1350-2d33-e063-6394a90a8bd72025-05-21WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEA-S Medication Solutions0be70365-57ee-4f2e-a30f-bdd5c292992d2025-02-20WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEA-S Medication Solutionsbaaf9c23-0b54-46a2-8aec-13264479a6d72025-02-20WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
LoratadineLORATADINEAmerican Health Packaging411f3692-99ff-49d7-8594-e6f404f5861f2024-11-21WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEProficient Rx LPa6b9a1bf-1013-4a15-b3b2-a226a75a1ffb2024-10-01WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEBryant Ranch Prepack40914eeb-3a85-4691-9fb8-2df72ba1f7092024-04-05WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEBryant Ranch Prepack94642b79-f91a-429f-87f4-dad326d4f3ed2024-04-03WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEOHM LABORATORIES INC.c35f2cc1-f76d-4824-b0a5-747bca0c3b852023-12-08WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Handy Solutions 24 Hour AllergyLORATADINENavajo Manufacturing Company Inc.67263031-9095-48f2-8b34-e589b28a74162023-03-15WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
LoratadineLORATADINESAFEWAY INC.1092b8af-25f2-4c25-b3bc-5ffb14e960242021-12-21WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
LoratadineLORATADINECVS Pharmacye63f082c-ff50-43ed-ad2c-598b352413e82021-12-21WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEDISCOUNT DRUG MART55d3ee36-116b-4ec6-b409-79d67a2b54ae2018-09-14WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134
Loratadine Allergy ReliefLORATADINEWinCo Foods, LLC506a60e8-7fec-4bb0-babc-204058ae120f2018-08-29WarningsExact identifier
application applno (ANDA): 076134
application number: ANDA076134

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367204acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
198440acetaminophen 500 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN5d185f23-8af6-4e36-b514-5662986520a51
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN5d185f23-8af6-4e36-b514-5662986520a51
308761bismuth subsalicylate 262 MG Chewable TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
1043690hydrocortisone acetate 1 % Topical CreamPSN5d185f23-8af6-4e36-b514-5662986520a51
310965ibuprofen 200 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
311372loratadine 10 MG 24HR Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
995666meclizine HCl 25 MG Oral TabletPSN5d185f23-8af6-4e36-b514-5662986520a51
1367204acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
198440acetaminophen 500 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD5d185f23-8af6-4e36-b514-5662986520a51
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD5d185f23-8af6-4e36-b514-5662986520a51
308761bismuth subsalicylate 262 MG Chewable TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
313884calcium carbonate 420 MG Chewable TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCD5d185f23-8af6-4e36-b514-5662986520a51
310965ibuprofen 200 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
311372loratadine 10 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
995666meclizine hydrochloride 25 MG Oral TabletSCD5d185f23-8af6-4e36-b514-5662986520a51
1367204APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51
198440APAP 500 MG Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY5d185f23-8af6-4e36-b514-5662986520a51
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY5d185f23-8af6-4e36-b514-5662986520a51
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY5d185f23-8af6-4e36-b514-5662986520a51
1043690hydrocortisone acetate 1 % Topical CreamSY5d185f23-8af6-4e36-b514-5662986520a51
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51
311372loratadine 10 MG 24 HR Oral TabletSY5d185f23-8af6-4e36-b514-5662986520a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82652-021-01826520021011 KIT in 1 CARTON (82652-021-01) * 1 TABLET, FILM COATED in 1 PACKET (82652-022-01) * 2 TABLET, FILM COATED in 1 PACKET (82652-025-01) * 2 TABLET in 1 PACKET (82652-030-01) * 2 TABLET in 1 PACKET * 1 TABLET, FILM COATED in 1 PACKET (82652-031-01) * 2 TABLET in 1 PACKET (82652-032-01) * 2 TABLET, CHEWABLE in 1 PACKET (82652-026-01) * 1 kit2022-05-100000-00-00NoNoCurrent