Allergy Relief

Product NDC
11822-0329
11-digit product format
118220329
Labeler code
11822
Product ID
11822-0329_573d4bd5-367e-4f13-a4f3-e0ca7bcfb2ee
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
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
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-032911822-0329-3DDiscontinued by firm2026-10-23
excluded packagepackage11822-032911822-0329-5DDiscontinued by firm2026-10-23
excluded packagepackage11822-032911822-0329-7DDiscontinued by firm2026-10-23
excluded packagepackage11822-032911822-0329-9DDiscontinued 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 · 48 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 2025-12-0511822-0329-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0511822-0329-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0511822-0329-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0511822-0329-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2611822-0329-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2611822-0329-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2611822-0329-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2611822-0329-5f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3111822-0329-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3111822-0329-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3111822-0329-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3111822-0329-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2811822-0329-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2811822-0329-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2811822-0329-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2811822-0329-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2111822-0329-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2111822-0329-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2111822-0329-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2111822-0329-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1011822-0329-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1011822-0329-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1011822-0329-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1011822-0329-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3111822-0329-7302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3111822-0329-9302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3111822-0329-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3111822-0329-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2011822-0329-7ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2011822-0329-9ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2011822-0329-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2011822-0329-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1011822-0329-70efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1011822-0329-90efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1011822-0329-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1011822-0329-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0811822-0329-7ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0811822-0329-9ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0811822-0329-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0811822-0329-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0311822-0329-7367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0311822-0329-9367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0311822-0329-5367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0311822-0329-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0911822-0329-7557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0911822-0329-9557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0911822-0329-5557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0911822-0329-3557ba5c1ecfa…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
2027-12-31

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
d5d9334d-3db6-4f45-ab84-3e1ec5a752c6Available 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
11822-0329-1Allergy Relief365 in 1 BOTTLE, PLASTICTABLET, FILM COATED36526
11822-0329-2Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10026
11822-0329-2Allergy Relief1 in 1 CARTONTABLET, FILM COATED126
11822-0329-3Allergy Relief1 in 1 PACKAGETABLET, FILM COATED126
11822-0329-3Allergy Relief10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1026
11822-0329-4Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1226
11822-0329-4Allergy Relief4 in 1 CARTONTABLET, FILM COATED426
11822-0329-5Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1226
11822-0329-5Allergy Relief1 in 1 CARTONTABLET, FILM COATED126
11822-0329-6Allergy Relief200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20026
11822-0329-6Allergy Relief1 in 1 CARTONTABLET, FILM COATED126
11822-0329-7Allergy Relief3 in 1 CARTONTABLET, FILM COATED326
11822-0329-7Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1226
11822-0329-8Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1226
11822-0329-8Allergy Relief2 in 1 CARTONTABLET, FILM COATED226
11822-0329-9Allergy Relief2 in 1 BLISTER PACKTABLET, FILM COATED226
11822-0329-9Allergy Relief1 in 1 CARTONTABLET, FILM COATED126

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0329ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RITE AID CORPORATION]25Current NDC, Legacy NDC, 17 package rows20240623_d5d9334d-3db6-4f45-ab84-3e1ec5a752c6.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 14 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
application number: M012
Giltuss Allergy PlusCHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp85a0dc7f-ffb5-7d52-e053-2991aa0a602a2026-07-23WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8590fcc9-c0dd-f43b-e053-2991aa0a692e2026-07-23WarningsExact identifier
application number: M012
Giltuss Sinus and Chest CongestionGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2f2-df65-e053-2a91aa0a42fb2026-07-23WarningsExact identifier
application number: M012
COLDTAC PlusACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEOPMX LLC3496866c-682f-420b-bfdb-64ecebbf70a22026-07-23WarningsExact identifier
application number: M012
nighttime cough dmDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.5a45b4c2-6a15-40b4-9ac6-d1554244ec422026-07-23WarningsExact identifier
application number: M012
DAY TIME NITE TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.6372cbdd-a3a3-499d-91ce-53bcdb83e7392026-07-23WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacydf6e522c-3e30-4aa0-8ab9-3b579c80bcad2026-07-22WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba2026-07-22WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEKenvue Brands LLC1c5386c1-e45d-9dcb-e063-6294a90aff072026-07-22WarningsExact identifier
application number: M012
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp772d0184-8c41-40f1-bbef-7e68692eec662026-07-22WarningsExact identifier
application number: M012
good sense allergyDIPHENHYDRAMINE HCLL. Perrigo Companybf5039a0-2109-41a2-84a9-b5167d0a93da2026-07-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNd5d9334d-3db6-4f45-ab84-3e1ec5a752c626
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDd5d9334d-3db6-4f45-ab84-3e1ec5a752c626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0329-111822032901365 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11822-0329-1) 1990-03-020000-00-00NoNoCurrent
11822-0329-2118220329021 BOTTLE, PLASTIC in 1 CARTON (11822-0329-2) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1990-03-020000-00-00NoNoCurrent
11822-0329-3118220329031 in 1 PACKAGEHistorical
11822-0329-4118220329044 BLISTER PACK in 1 CARTON (11822-0329-4) / 12 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack1990-03-020000-00-00NoNoCurrent
11822-0329-5118220329051 BLISTER PACK in 1 CARTON (11822-0329-5) > 12 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1990-03-022021-10-08NoNoCurrent
11822-0329-6118220329061 BOTTLE, PLASTIC in 1 CARTON (11822-0329-6) / 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1990-03-020000-00-00NoNoCurrent
11822-0329-7118220329073 in 1 CARTONHistorical
11822-0329-8118220329082 BLISTER PACK in 1 CARTON (11822-0329-8) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack1990-03-020000-00-00NoNoCurrent
11822-0329-9118220329091 BLISTER PACK in 1 CARTON (11822-0329-9) > 2 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1990-03-020000-00-00NoNoCurrent