Home NDC 66424-021 Diphenhydramine HCL
Product NDC 66424-021
11-digit product format 664240021
Labeler code 66424
Product ID 66424-021_2ba30474-41ba-6c1a-e063-6394a90a9631
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCL
Dosage form CAPSULE
Route ORAL
Labeler SDA Laboratories, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-01-27
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 50 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 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, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66424-021-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66424-021-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 66424-021-10 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 66424-021-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 66424-021-10 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 66424-021-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 66424-021-10 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 66424-021-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 66424-021-10 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 66424-021-01 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 66424-021-10 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 66424-021-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66424-021-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66424-021-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66424-021-10 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66424-021-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Diphenhydramine HCL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020477 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66424-021-01 Diphenhydramine HCL 100 in 1 BOTTLE, PLASTIC CAPSULE 100 3 66424-021-10 Diphenhydramine HCL 1000 in 1 BOTTLE, PLASTIC CAPSULE 1000 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 2 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66424-021 DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20250115_437e6a13-a4ff-4f98-8973-042f224ee85e.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 132 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 82813342-2be2-4731-ae90-dbd5eed667a9 2024-12-10 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. b640a5d2-a7fe-486d-a65f-e7c993f950d6 2024-12-10 Warnings Exact identifier application number: M012 Sugar Free Mountain Herb Cough Suppressant Throat Drops MENTHOL Ricola USA Inc. c3f3c062-55e5-43c1-a016-ee47a7b388a5 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola USA Inc. ee4733b5-6e5a-438a-97da-110f3ef6c809 2024-12-10 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola USA Inc. f62fcc38-2d43-40b3-841f-c8eea9ebd1e1 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 8a6db093-7e52-443f-8dd6-94867606fef8 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola USA Inc. 5885343e-4a6e-44f7-87a4-d52599156197 2024-12-10 Warnings Exact identifier application number: M012 EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola USA Inc. 0baf383c-886d-47ca-8a6d-221298c79446 2024-12-10 Warnings Exact identifier application number: M012 Tussin Multi Symptom Cold CF DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE Best Choice (Valu Merchandisers Company) 539b8972-2a46-468e-ad27-6672d746feb7 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. db2ab9be-507d-4768-9d00-188f751b7726 2024-12-10 Warnings Exact identifier application number: M012 Adult Allergy Relief CALMCO ALLERGY RELIEF CalmCo 08288825-0f38-b6a3-e063-6394a90aa358 2024-12-07 Warnings Exact identifier application number: M012 Original Herb Cough Drops MENTHOL Ricola Ag c142663f-086e-4ab7-a758-9107d7077537 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 984c9793-163c-4b97-b244-9b471966a122 2024-12-05 Warnings Exact identifier application number: M012 BENZEDREX PROPYLHEXEDRINE BF ASCHER AND CO INC 00d8c237-3eee-1d9f-e063-6394a90aeb86 2024-12-05 Warnings Exact identifier application number: M012 Cold Multi Symptom Daytime Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE Chain Drug Marketing Association d5cbb5b0-564c-429e-b680-fa683e796393 2024-12-05 Warnings Exact identifier application number: M012 Cold Relief Multi-Symptom ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCare de8a623f-7b10-4d56-a74b-3737e7716ffe 2024-12-05 Warnings Exact identifier application number: M012 Cold Max Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 9773958b-c5e5-4da7-a8e9-6b6c223a2b30 2024-12-05 Warnings Exact identifier application number: M012 Cold Plus Head Congestion Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE TopCo Associates LLC 399e0e51-c2a7-451c-b74d-d3db140cef69 2024-12-05 Warnings Exact identifier application number: M012 Head Congestion Plus Mucus PE ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE United Natural Foods, Inc. dba UNFI 09531edc-8dbd-451f-ae02-f922e9e8c248 2024-12-05 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola Ag 71ca8af7-172d-40da-be1e-ff3ab5568e74 2024-12-05 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 66424-021-01 66424002101 100 CAPSULE in 1 BOTTLE, PLASTIC (66424-021-01) 100 capsule 2010-01-27 No No Current 66424-021-10 66424002110 1000 CAPSULE in 1 BOTTLE, PLASTIC (66424-021-10) 1000 capsule 2010-01-27 No No Current