allergy

Product NDC
56062-479
11-digit product format
560620479
Labeler code
56062
Product ID
56062-479_d0b0bff2-487d-4fe0-a933-3ca2c6d07596
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Publix Super Markets Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-05-07
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 packagepackage56062-47956062-479-62DDiscontinued by firm2026-10-16
excluded packagepackage56062-47956062-479-67DDiscontinued 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 · 20 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 2025-12-0556062-479-62d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0556062-479-67d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2656062-479-62f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2656062-479-67f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3156062-479-622ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3156062-479-672ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2856062-479-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2856062-479-67a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2156062-479-62cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2156062-479-67cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1056062-479-62cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1056062-479-67cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3156062-479-62302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3156062-479-67302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2056062-479-62ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2056062-479-67ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1056062-479-620efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1056062-479-670efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0856062-479-67ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0356062-479-67367a005e9d99…383a685ebd0f…

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
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
23a98385-28cc-4fac-8c87-b3ced8106532Available 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-479-62allergy24 in 1 CARTONTABLET247
56062-479-62allergy1 in 1 BLISTER PACKTABLET17
56062-479-67allergy1 in 1 BLISTER PACKTABLET17
56062-479-67allergy48 in 1 CARTONTABLET487
56062-479-78allergy100 in 1 BOTTLETABLET1007
56062-479-78allergy1 in 1 CARTONTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
56062-479-62EA - Each56062-479d2cf61c4-ba45-4d60-9400-745f0775349b12013-09-04
56062-479-67EA - Each56062-479442a691a-7f8c-41a7-9d18-739a879f46ed12013-09-04
56062-479-78EA - Each56062-4795d6e0869-6e01-4fd8-8d13-9b794e22969d12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-479ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [PUBLIX SUPER MARKETS INC]7Current NDC, Legacy NDC, 6 package rows20240722_23a98385-28cc-4fac-8c87-b3ced8106532.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 23 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu Severe Congestion Relief Cooling Nasal MistOXYMETAZOLINE HCLHaleon US Holdings LLC90125a19-eed7-4ca4-a6dc-f38026c74d542026-06-08WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company54254b61-7861-4eeb-bd3c-54fd5266f4a72026-06-08WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINMajor Pharmaceuticalsaa662428-e61f-4e22-af4d-8cf63df68c992026-06-08WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN, GUAIFENESIN AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLTARGET CORPORATION47a218a0-6395-36bd-e063-6394a90a265a2026-06-05WarningsExact identifier
application number: M012
Daytime NighttimeACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCLTARGET CORPORATION4779288a-9850-8490-e063-6394a90abe512026-06-05WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max and Mucinex Fast-Max Nighttime DM Max Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN AND TRIPROLIDINE HCLReckitt Benckiser LLC4df37cfb-299f-661f-e063-6394a90ab3372026-06-04WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEBayer HealthCare LLC.53715ea4-42b3-5887-e063-6294a90a42492026-06-04WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association, Inc.b0d38db9-22a9-4dd8-8e0f-dd81805e724b2026-06-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY65d4d7ea-c080-404e-9836-7d6bdcc5ea7d2026-06-04WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDfe9d6a6e-38a1-44ae-a30f-596c5ec7d0572026-06-03WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companyb0c1d635-0f85-433a-b479-51c68d259faa2026-06-03WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWalgreen Companyde4e8af4-d3d0-44b3-aea3-79016803ccdc2026-06-03WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR AND GUAIFENESINARMY AND AIR FORCE EXCHANGE SERVICEdc0a3761-bbe2-4261-a183-594f5fb12b0b2026-06-03WarningsExact identifier
application number: M012
Cold and Flu Daytime, NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWALMART INC.f278cc81-65b2-4e45-be5b-41152cbb67c42026-06-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamily Dollar Services Inc358ba91d-06a4-49c9-994d-4e4bf9499dcd2026-06-03WarningsExact identifier
application number: M012
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANCardinal Health 107, LLCc5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed2026-06-02WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5349dbde-730c-610f-e063-6394a90a952a2026-06-02WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATECardinal Health 107, LLCa9130f36-4761-4e6b-a383-eca3db06ea932026-06-02WarningsExact identifier
application number: M012
Topcare Day Time Nite Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLTopco Associates LLCaed387e0-5a8b-4caf-a373-3e04496a49832026-06-02WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid DayACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.53371691-2510-5039-e063-6394a90a6ea92026-06-01WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN23a98385-28cc-4fac-8c87-b3ced81065327
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD23a98385-28cc-4fac-8c87-b3ced81065327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-479-625606204796224 BLISTER PACK in 1 CARTON (56062-479-62) > 1 TABLET in 1 BLISTER PACK24 blister pack1998-05-070000-00-00NoNoCurrent
56062-479-675606204796748 BLISTER PACK in 1 CARTON (56062-479-67) > 1 TABLET in 1 BLISTER PACK48 blister pack2002-04-180000-00-00NoNoCurrent
56062-479-78560620479781 BOTTLE in 1 CARTON (56062-479-78) / 100 TABLET in 1 BOTTLE1 bottle2007-11-260000-00-00NoNoCurrent