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 71 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Honey Lemon cough drops MENTHOL Walmart Stores Inc. 317bbd33-6087-3af1-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Good Sense Nasal Decongestant PSEUDOEPHEDRINE HCL L. Perrigo Company 455b35b4-3969-411b-8036-887615d71e11 2025-12-21 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Safeway Inc. 4a4f7f82-1b6c-7082-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 Cherry Cough Drop MENTHOL Safeway Inc. 4a52c0c2-8659-2819-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Cherry Cough Drops MENTHOL Safeway a733e905-af15-d3ea-e053-2a95a90aa7c3 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Honey Lemon Cough Drops MENTHOL Safeway a742449f-c76b-2b91-e053-2a95a90ae4d2 2025-12-20 Warnings Exact identifier application number: M012 Cherry Sore Throat Lozenge BENZOCAINE TopCo 60b876e7-c642-5ce8-e053-2a91aa0abd6e 2025-12-20 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Topco Associates 366cc6b1-beff-29d2-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL TopCo Associates 3fef2117-7311-1e66-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Topco Associates 3ff1bf05-e407-3b67-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free menthol cough drops MENTHOL Topco Associates 36727f0c-d6d2-28a3-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL Topco Associates 36824bee-607e-7095-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Mixed Berry Sore Throat Lozenges BENZOCAINE Topco Associates 7a00c771-9231-e877-e053-2a91aa0ac96e 2025-12-20 Warnings Exact identifier application number: M012 MUCUS RELIEF GUAIFENESIN 400 MG NUVICARE LLC e25b440e-f389-443f-b333-c66ad1747158 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu severe ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL Wal-Mart Stores Inc 9fca25dc-f63e-487a-8b7c-84d65ea51cb5 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Geiss, Destin & Dunn Inc. a7d2eaee-484e-43aa-8ae3-0e050219383f 2025-12-19 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Publix 66d8e5f7-9766-57f3-e053-2991aa0a7e17 2025-12-19 Warnings Exact identifier application number: M012 Honey Lemon Cough Drops MENTHOL Publix 66e89fa3-ee09-1d16-e053-2a91aa0ae17c 2025-12-19 Warnings Exact identifier application number: M012 Poly-Vent DM DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL Poly Pharmaceuticals, Inc. 739329ae-0b62-4eab-a07d-867b5d3d61e0 2025-12-19 Warnings Exact identifier application number: M012 Chest Congestion and Cough Relief DM DEXTROMETHORPHAN HBR, GUAIFENESIN ARMY AND AIR FORCE EXCHANGE SERVICE 89494a7c-cdbf-48f1-aaa9-2e57d4388a68 2025-12-19 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