good sense allergy relief

Product NDC
0113-0479
11-digit product format
001130479
Labeler code
0113
Product ID
0113-0479_76ee13f5-338f-4c02-89f0-4a862333353e
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-08-20
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
2027-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0113-04790113-0479-53DDiscontinued by firm2026-10-23
excluded packagepackage0113-04790113-0479-62DDiscontinued by firm2026-10-23
excluded packagepackage0113-04790113-0479-67DDiscontinued by firm2026-10-23

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 · 24 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 2025-12-050113-0479-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050113-0479-67d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260113-0479-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260113-0479-67f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310113-0479-532ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310113-0479-672ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280113-0479-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280113-0479-67a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210113-0479-53cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210113-0479-67cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100113-0479-53cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100113-0479-67cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310113-0479-53302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310113-0479-67302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200113-0479-53ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200113-0479-67ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100113-0479-530efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100113-0479-670efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080113-0479-53ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080113-0479-67ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030113-0479-53367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030113-0479-67367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090113-0479-53557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090113-0479-67557ba5c1ecfa…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
good sense allergy relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

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
0113-0479-53good sense allergy relief1 in 1 BLISTER PACKTABLET19
0113-0479-53good sense allergy relief12 in 1 CARTONTABLET129
0113-0479-62good sense allergy relief24 in 1 CARTONTABLET249
0113-0479-62good sense allergy relief1 in 1 BLISTER PACKTABLET19
0113-0479-67good sense allergy relief48 in 1 CARTONTABLET489
0113-0479-67good sense allergy relief1 in 1 BLISTER PACKTABLET19
0113-0479-78good sense allergy relief100 in 1 BOTTLETABLET1009
0113-0479-78good sense allergy relief1 in 1 CARTONTABLET19
0113-0479-79good sense allergy relief400 in 1 BOTTLETABLET4009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0479-53EA - Each0113-0479ee7a9bd6-c9e5-4049-a57f-f0df7b23a1c912018-02-20
0113-0479-62EA - Each0113-04798f6a54c4-4fa6-4bf7-a24a-10810f8a4ac412013-02-13
0113-0479-78EA - Each0113-0479d935c09b-7aa6-4a73-a496-1316061e792112013-02-13
0113-0479-79EA - Each0113-04794a7a8732-c938-489c-a655-e838ed92030012020-09-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40GOOD SENSE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MGOOD SENSE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JGOOD SENSE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGOOD SENSE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGOOD SENSE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGOOD SENSE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGOOD SENSE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0479GOOD SENSE ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [L. PERRIGO COMPANY]9Current NDC, Legacy NDC, 9 package rows20240202_2cfa69b4-e33f-442a-a6df-b021b041da14.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 95 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)90ccb29c-9967-46cb-a409-e440344e1a1a2025-10-15WarningsExact identifier
application number: M012
Robitussin Childrens Honey Day Night DM Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCf9999875-3433-4052-a628-39539d3732162025-10-15WarningsExact identifier
application number: M012
Robitussin Day and Night Cough Relief Value PackDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATEHaleon US Holdings LLC4029eccd-5443-4ae2-9232-2a1d922798f82025-10-15WarningsExact identifier
application number: M012
EndaCof DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.c68ea55a-8b9a-4a70-8b5c-1a27366518132025-10-15WarningsExact identifier
application number: M012
DURATUSS DMDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.413a3951-d704-f14b-e063-6394a90a06dc2025-10-15WarningsExact identifier
application number: M012
LoHist DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.29730dab-fa09-4351-9b36-0359ba4f77442025-10-15WarningsExact identifier
application number: M012
M-END DMXDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDER. A. McNeil Companyee1fae2e-3a21-4487-9989-c7620a4a70562025-10-15WarningsExact identifier
application number: M012
Chlo TussCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDER.A. McNeil Company43610aaa-8b94-40d5-ae09-3d75bd2317c82025-10-15WarningsExact identifier
application number: M012
Chlo HistCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATER. A. McNeil Companyd046f4ba-5753-4ed5-a924-0b66fd1167812025-10-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)6ca7372b-50c4-4b15-b133-fefa35525ade2025-10-15WarningsExact identifier
application number: M012
Extra Strength Sinus Relief Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH0d8a009c-30b5-4f12-90bd-f8aa1110243f2025-10-14WarningsExact identifier
application number: M012
Tussin DM Cough plus Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCardinal Health 110, Inc. DBA LEADER9d11f443-c93d-44e8-b5a3-2677b7b112122025-10-14WarningsExact identifier
application number: M012
Rompe Pecho SFGUAIFENESINEfficient Laboratories, Inc.31ff48fc-9603-413c-ab7c-2598b3e08f9c2025-10-14WarningsExact identifier
application number: M012
Rompe Pecho DMDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Incd108c712-bc36-41d7-9ccd-720496b5599e2025-10-14WarningsExact identifier
application number: M012
Rompe Pechito DM for KidsDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc004d12e1-6e3d-84c8-e063-6394a90aa6532025-10-14WarningsExact identifier
application number: M012
VANACOF CP Allergy / CoughCHLOPHEDIANOL HCL, PYRILAMINE MALEATEGM Pharmaceuticals, INC0bdea30a-39da-6611-e063-6394a90aa4cf2025-10-14WarningsExact identifier
application number: M012
VANACOFCHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDEGM Pharmaceuticals, INCcf3886ab-62b3-497a-a587-18cbfbaf36342025-10-14WarningsExact identifier
application number: M012
Sugar Free Cherry Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.42d4bafb-b630-487e-b63d-13ad37a594542025-10-14WarningsExact identifier
application number: M012
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc410c19f7-213d-cd99-e063-6294a90af5a32025-10-13WarningsExact identifier
application number: M012
TexaClear Pain and Chest Congestion ReliefCHOLINE SALICYLATE,GUAIFENESINGM Pharmaceuticals, INC672bc78a-2c71-4135-b64a-2b8c40ac688c2025-10-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2cfa69b4-e33f-442a-a6df-b021b041da149
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2cfa69b4-e33f-442a-a6df-b021b041da149
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea45
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0479-530011304795312 BLISTER PACK in 1 CARTON (0113-0479-53) > 1 TABLET in 1 BLISTER PACK12 blister pack2016-08-100000-00-00NoNoCurrent
0113-0479-62001130479621 BOTTLE in 1 CARTON (0113-0479-62) > 24 TABLET in 1 BOTTLE1 bottle1991-08-200000-00-00NoNoCurrent
0113-0479-670011304796748 BLISTER PACK in 1 CARTON (0113-0479-67) > 1 TABLET in 1 BLISTER PACK48 blister pack2021-06-040000-00-00NoNoCurrent
0113-0479-78001130479781 BOTTLE in 1 CARTON (0113-0479-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle1993-10-060000-00-00NoNoCurrent
0113-0479-7900113047979400 TABLET, FILM COATED in 1 BOTTLE (0113-0479-79) 2001-02-260000-00-00NoNoCurrent