FDA.reportPublic FDA data

Allergy Relief

Product NDC
59779-923
11-digit product format
597790923
Labeler code
59779
Product ID
59779-923_ada07bd0-7187-441a-a1ca-21445824fdca
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-03-02
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59779-92359779-923-06DDiscontinued by firm2026-10-16
excluded packagepackage59779-92359779-923-07DDiscontinued by firm2026-10-16

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 · 14 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0559779-923-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559779-923-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2659779-923-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659779-923-07f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3159779-923-072ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2859779-923-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2159779-923-07cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1059779-923-07cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3159779-923-07302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2059779-923-07ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1059779-923-070efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0859779-923-07ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0359779-923-07367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0959779-923-07557ba5c1ecfa…9c80585c8c6e…

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
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
22f55699-4922-4c05-bdf5-5844c7dd3ee5Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-923-03Allergy Relief10 in 1 BOTTLETABLET, FILM COATED1021
59779-923-03Allergy Relief1 in 1 PACKAGETABLET, FILM COATED121
59779-923-06Allergy Relief1 in 1 CARTONTABLET, FILM COATED121
59779-923-06Allergy Relief200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20021
59779-923-07Allergy Relief1 in 1 CARTONTABLET, FILM COATED121
59779-923-07Allergy Relief36 in 1 BLISTER PACKTABLET, FILM COATED3621
59779-923-08Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1221
59779-923-08Allergy Relief2 in 1 CARTONTABLET, FILM COATED221
59779-923-12Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10021
59779-923-12Allergy Relief1 in 1 CARTONTABLET, FILM COATED121
59779-923-22Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1221
59779-923-22Allergy Relief4 in 1 CARTONTABLET, FILM COATED421
59779-923-51Allergy Relief365 in 1 BOTTLETABLET, FILM COATED36521

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-923-06EA - Each59779-92330110bad-301f-4dad-805c-dfa36e7445b912018-06-11
59779-923-08EA - Each59779-923168d7f4c-0736-4b11-aa63-0fcbfcf2c6db12019-07-02
59779-923-12EA - Each59779-92372268e8a-847e-45bc-88b4-ed051ce515c312017-12-14
59779-923-22EA - Each59779-9239e7cf901-db0a-4cba-aea8-17393dd51c7f12019-07-02
59779-923-51EA - Each59779-923ba2d6332-2a3c-4a5c-b542-aeaea5afed8812017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-923ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [CVS PHARMACY]20Current NDC, Legacy NDC, 13 package rows20250105_22f55699-4922-4c05-bdf5-5844c7dd3ee5.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 69 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Menthol Chewable GelsMENTHOLWalmart1ba4b2be-7242-0a23-e063-6294a90af29c2025-12-23WarningsExact identifier
application number: M012
Walgreens Severe Menthol Throat DropsMENTHOLWalgreens21dd3c68-cbc6-4799-e063-6394a90a69722025-12-23WarningsExact identifier
application number: M012
cherry throat relief lozengesBENZOCAINEZee Medical499d0748-538f-678c-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
Guaiasorb DMDEXTROMETHORPHAN HBR, GUAIFENESINNuCare Pharmaceuticals, Inc.46a480c7-7092-b809-e063-6294a90a60cd2025-12-23WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLWinco Foods360a6304-206d-5475-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLWinco Foods36342d8c-34ab-6178-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLWinco Foods37244333-1307-5121-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLWinco foods37718c73-880e-4a5c-e054-00144ff8d46c2025-12-23WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLWinco Foods40676ddc-577f-5cc9-e054-00144ff88e882025-12-23WarningsExact identifier
application number: M012
Sugar Free Menthol Cough DropsMENTHOLWinco Foods3788e8b6-ab9e-1513-e054-00144ff88e882025-12-23WarningsExact identifier
application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestionDEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIESeeca6370-29ea-4540-8139-e8461d58a2862025-12-23WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDiscount Drug Martdd31f86b-f59e-459a-8e5f-176828706a4a2025-12-23WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDiscount Drug Martf8e7a08e-7422-4a1b-bfec-93e0b50d10cd2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCab45ae97-7951-4058-e053-2995a90a7b2e2025-12-23WarningsExact identifier
application number: M012
Childrens Chest Congestion Relief GrapeGUAIFENESINDiscount Drug Mart3e5d245f-515c-4106-a855-fb97681b646a2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCab45ed16-86bb-3faf-e053-2995a90acfbc2025-12-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCa7999da7-148a-4c6d-a2ea-0f4cc1d5b2832025-12-23WarningsExact identifier
application number: M012
Safetussin High Blood Pressure and diabetes Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES279e309c-040d-4001-808d-b7d986a9a1d82025-12-23WarningsExact identifier
application number: M012
Sinus PE Head Congestion and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED76fd1f8e-2670-421c-a9e6-c8adefb7962e2025-12-23WarningsExact identifier
application number: M012
Leader Cough Drops Vanilla HoneyMENTHOLCardinal Health 110, LLC. DBA Leader1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e22025-12-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN22f55699-4922-4c05-bdf5-5844c7dd3ee521
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD22f55699-4922-4c05-bdf5-5844c7dd3ee521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-923-03597790923031 BOTTLE in 1 PACKAGE (59779-923-03) / 10 TABLET, FILM COATED in 1 BOTTLE1 bottle1990-03-020000-00-00NoNoCurrent
59779-923-06597790923061 BOTTLE, PLASTIC in 1 CARTON (59779-923-06) > 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1990-03-020000-00-00NoNoCurrent
59779-923-07597790923071 in 1 CARTONHistorical
59779-923-08597790923082 BLISTER PACK in 1 CARTON (59779-923-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack1990-03-020000-00-00NoNoCurrent
59779-923-12597790923121 BOTTLE, PLASTIC in 1 CARTON (59779-923-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1990-03-020000-00-00NoNoCurrent
59779-923-22597790923224 BLISTER PACK in 1 CARTON (59779-923-22) / 12 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack1990-03-020000-00-00NoNoCurrent
59779-923-5159779092351365 TABLET, FILM COATED in 1 BOTTLE (59779-923-51) 1990-03-020000-00-00NoNoCurrent