Home NDC 66424-021-01 Diphenhydramine HCL
Product NDC 66424-021
Requested package NDC 66424-021-01
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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 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 68 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate SF Menthol Cough Drops MENTHOL WalMart 003a229c-b014-e9f3-e063-6294a90aa5ed 2025-12-23 Warnings Exact identifier application number: M012 Equate Menthol Cough Drops MENTHOL Walmart 124e6968-f59c-39d4-e063-6294a90a66d4 2025-12-23 Warnings Exact identifier application number: M012 Equate Severe Menthol Throat Drop MENTHOL Walmart 125f3f5a-52aa-e398-e063-6394a90a0012 2025-12-23 Warnings Exact identifier application number: M012 Equate Menthol Chewable Gels MENTHOL Walmart 1ba4b2be-7242-0a23-e063-6294a90af29c 2025-12-23 Warnings Exact identifier application number: M012 Walgreens Severe Menthol Throat Drops MENTHOL Walgreens 21dd3c68-cbc6-4799-e063-6394a90a6972 2025-12-23 Warnings Exact identifier application number: M012 cherry throat relief lozenges BENZOCAINE Zee Medical 499d0748-538f-678c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 Guaiasorb DM DEXTROMETHORPHAN HBR, GUAIFENESIN NuCare Pharmaceuticals, Inc. 46a480c7-7092-b809-e063-6294a90a60cd 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 360a6304-206d-5475-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 36342d8c-34ab-6178-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Winco Foods 37244333-1307-5121-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco foods 37718c73-880e-4a5c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco Foods 40676ddc-577f-5cc9-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 Sugar Free Menthol Cough Drops MENTHOL Winco Foods 3788e8b6-ab9e-1513-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 SAFETUSSIN Non Drowsy Cough plus chest congestion DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN KRAMER LABORATORIES eeca6370-29ea-4540-8139-e8461d58a286 2025-12-23 Warnings Exact identifier application number: M012 Tussin DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Discount Drug Mart dd31f86b-f59e-459a-8e5f-176828706a4a 2025-12-23 Warnings Exact identifier application number: M012 Tussin CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Discount Drug Mart f8e7a08e-7422-4a1b-bfec-93e0b50d10cd 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ae97-7951-4058-e053-2995a90a7b2e 2025-12-23 Warnings Exact identifier application number: M012 Childrens Chest Congestion Relief Grape GUAIFENESIN Discount Drug Mart 3e5d245f-515c-4106-a855-fb97681b646a 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ed16-86bb-3faf-e053-2995a90acfbc 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC a7999da7-148a-4c6d-a2ea-0f4cc1d5b283 2025-12-23 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