FDA.reportPublic FDA data

careone allergy relief

Product NDC
41520-778
11-digit product format
415200778
Labeler code
41520
Product ID
41520-778_703c7305-4a5a-4d22-ae35-db8657dccf8c
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Sales Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-21
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage41520-77841520-778-62DDiscontinued by firm2026-10-20

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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
careone allergy relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed4038fc-ab39-4567-9961-2b390b91b126Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-778-622024-01-30C16284748780-11030e364-fda6-111a-e063-dadaa90a10e2American Sales Company Allergy Relief Drug Facts
41520-778-782024-01-30C16284748780-11030e364-fda6-111a-e063-dadaa90a10e2American Sales Company Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-778-62careone allergy relief24 in 1 CARTONTABLET245
41520-778-62careone allergy relief1 in 1 BLISTER PACKTABLET15
41520-778-78careone allergy relief1 in 1 CARTONTABLET15
41520-778-78careone allergy relief100 in 1 BOTTLETABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-778CAREONE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERICAN SALES COMPANY]5Current NDC, Legacy NDC, 4 package rows20240719_ed4038fc-ab39-4567-9961-2b390b91b126.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 138 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care daytime severe cold and flu nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f22024-11-15WarningsExact identifier
application number: M012
Rompe Pecho EXGUAIFENESINEfficient Laboratories Inc89ea23a5-0da7-407e-83d9-77a0b562f3af2024-11-14WarningsExact identifier
application number: M012
basic care daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLCceb342da-ff6d-4c19-9f78-0033d028075e2024-11-14WarningsExact identifier
application number: M012
Topcare Nite Time Day Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLCefb8e0e2-0795-4f4a-8ca6-955f33bee1432024-11-14WarningsExact identifier
application number: M012
good neighbor pharmacy nasal fourPHENYLEPHRINE HYDROCHLORIDEAmerisource Bergena3d637dc-d957-458c-8a75-f948601a31aa2024-11-14WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEMeijer Distribution Incec8db98f-4fd1-4644-b76f-ff04f72e87f42024-11-13WarningsExact identifier
application number: M012
dg health tussinDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, LLC6f9b8267-1e0b-430b-8e44-06408ae82ea42024-11-13WarningsExact identifier
application number: M012
Walgreens Effervescent Cold Relief PlusASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEWalgreensb60e2cf9-11ec-469e-e053-2a95a90a712a2024-11-13WarningsExact identifier
application number: M012
Kroger Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEKroger Company69333774-3cf4-384d-e053-2a91aa0a48b32024-11-13WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEH. E. Butt Grocery Company6403fe3d-d82b-f4d5-e053-2991aa0ac7d62024-11-13WarningsExact identifier
application number: M012
Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATETopco Associates LLCa2929bcb-fa81-4f15-b087-a9996b5e7d1f2024-11-13WarningsExact identifier
application number: M012
Equate Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEWalmart6271bb48-74b2-eb57-e053-2991aa0afd1b2024-11-13WarningsExact identifier
application number: M012
Equaline Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEUnited Natural Foods, Inc. dba UNFI6bf341e0-94b1-08ff-e053-2991aa0af6342024-11-13WarningsExact identifier
application number: M012
Good Sense Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEGood Sensecd25e250-bb8b-7e83-e053-2a95a90a26392024-11-13WarningsExact identifier
application number: M012
Top Value Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATETower Laboratories Ltd440a00b1-7960-0cc4-e054-00144ff8d46c2024-11-13WarningsExact identifier
application number: M012
Top Value Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATETower Laboratories Ltd.c6f207e8-bc0d-853a-e053-2a95a90ac6232024-11-13WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEDOLGENCORP, LLC7fad8e65-34fe-5313-e053-2a91aa0a56f42024-11-13WarningsExact identifier
application number: M012
Dollar General Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATEDOLGENCORP, LLC7face5c7-f5c7-7eee-e053-2991aa0ab0642024-11-13WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief PlusASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEChain Drug Marketing Association90622927-9682-4eb0-8c7f-894230b3dda42024-11-13WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca2024-11-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNed4038fc-ab39-4567-9961-2b390b91b1265
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDed4038fc-ab39-4567-9961-2b390b91b1265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-778-624152007786224 BLISTER PACK in 1 CARTON (41520-778-62) > 1 TABLET in 1 BLISTER PACK24 blister pack2017-09-210000-00-00NoNoCurrent
41520-778-78415200778781 BOTTLE in 1 CARTON (41520-778-78) / 100 TABLET in 1 BOTTLE1 bottle2017-09-210000-00-00NoNoCurrent