good sense allergy relief

Product NDC
0113-0479
11-digit product format
001130479
Labeler code
0113
Product ID
0113-0479_9f4c73e7-71c5-4a82-819b-a39ee74f4145
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
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
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 packagepackage0113-04790113-0479-53DDiscontinued by firm2026-10-21
excluded packagepackage0113-04790113-0479-67DDiscontinued by firm2026-10-21

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
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
2cfa69b4-e33f-442a-a6df-b021b041da14Available 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
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 61 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Berkley and Jensen Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINBJWCc15b97a8-968f-4d38-905e-863e9fd16ce62026-01-06WarningsExact identifier
application number: M012
Complete Allergy MedicineDIPHENHYDRAMINE HCLSalado Sales, Inc.c0f5c8ca-b187-40bf-9245-6a29f1c32c972026-01-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leaderc5776b1e-9f72-4a6a-9961-8ac8e05b32492026-01-06WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb9215a5e-3be8-44fd-9189-50dab760869c2026-01-06WarningsExact identifier
application number: M012
Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMajor Pharmaceuticalsf81efbf4-204b-45be-ae32-910d9e4ae4aa2026-01-06WarningsExact identifier
application number: M012
SINUS AND NASAL DECONGESTANTPSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd7646859-f996-46cd-a0b9-56b860f609012026-01-05WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLHY-VEE, INC47a71cdf-856d-9ecd-e063-6294a90a70c62026-01-05WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINOncor Pharmaceuticalsfd35036c-b722-48a3-85fd-60471beb6e742026-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLNuCare Pharmaceuticals,Inc.3c323dc8-f734-b44c-e063-6394a90a61842026-01-05WarningsExact identifier
application number: M012
Congestion and Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf43d97b1-aeb9-4ca5-8909-b28e7bf764f52026-01-05WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWinCo Foods, LLC6bd2b8fd-2023-413b-8988-a47d2058dc852026-01-05WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWinCo Foods, LLC4c1046df-53a6-4219-83ac-bbf5cf4db9c82026-01-05WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC80323208-9ba5-432b-a8a0-0c0b51e671452026-01-05WarningsExact identifier
application number: M012
Sinus Pressure and Pain PE Maximum StrengthACETAMINOPHEN AND PHENYLEPHRINE HCLRite Aid Corporation347868e4-0182-4e16-895c-ec269895c57c2026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops CherryMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.c5b11a9c-6d93-4772-93c2-1ef5c56470162026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.fae96736-1453-42fe-8158-cde770b231652026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd2026-01-02WarningsExact identifier
application number: M012
Reliable-1 TussinGUAIFENESINRELIABLE 1 LABORATORIES LLC2a33ff82-49df-7aaa-e063-6294a90a12812026-01-02WarningsExact identifier
application number: M012
Tussin DMMaxDEXTROMETHORPHAN HBR, GUAIFENESINRELIABLE 1 LABORATORIES LLCc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa2026-01-02WarningsExact identifier
application number: M012
Severe Sinus Pain and Congestion DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy4af347ce-9745-4a5e-8ce9-e7c97a0a6cc72026-01-02WarningsExact 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 in 1 BOTTLE1 bottle1993-10-060000-00-00NoNoCurrent
0113-0479-7900113047979400 TABLET in 1 BOTTLE (0113-0479-79) 400 tablet2001-02-260000-00-00NoNoCurrent