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.
| 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 |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1020477 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 437e6a13-a4ff-4f98-8973-042f224ee85e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 66424-021-01 | 2023-06-13 | Drug Facts |
| 66424-021-10 | 2023-06-13 | Drug Facts |
| 66424-021-01 | 2020-01-31 | Drug Facts |
| 66424-021-10 | 2020-01-31 | Drug Facts |
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66424-021-01 | EA - Each | 66424-021 | 9776653f-7c63-4b8b-a643-b1ff64504064 | 1 | 2012-07-24 |
| 66424-021-10 | EA - Each | 66424-021 | fa4dd348-3929-4217-a7fb-c7f312f780c8 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Childrens Cold and Cough Nighttime | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Safeway, Inc. | cbbec807-f882-4c6a-b1cd-c7fd5ce70cad | 2024-05-15 | Warnings | M012 |
| Cold and Flu Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | d6ac0d70-0511-4ec8-bb35-8b2e0e3d7742 | 2024-05-15 | Warnings | M012 |
| Night Time Cough | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | f658a03b-6fc2-4b63-b3ab-7e886fbf20b4 | 2024-05-15 | Warnings | M012 |
| AXIV DM Max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | VIVUNT PHARMA LLC | 18704e66-ee8f-315d-e063-6294a90a5282 | 2024-05-14 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Target Corporation Inc. | 187622dc-ecde-181d-e063-6294a90a4e8f | 2024-05-14 | Warnings | M012 |
| Lemon Mint Drops | MENTHOL | Target Corporation Inc. | 1876df19-398a-23d8-e063-6394a90ae7e8 | 2024-05-14 | Warnings | M012 |
| Cold Flu and Sore Throat Relief Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Safeway, Inc. | 6c952c81-c8b6-4e74-abd8-781f6f44736b | 2024-05-14 | Warnings | M012 |
| Pain and Sinus Reliever | ACETAMINOPHEN AND PHENYLEPHRINE | JHK DBA American Safety & First Aid | 249373c6-f56f-4bd3-9cef-98b7ee73457d | 2024-05-14 | Warnings | M012 |
| Nasal | PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | fea71cb9-e044-4729-ad26-1db0cdb9dd11 | 2024-05-14 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | a70ead03-6d2c-44c1-9ae5-f6c4094821ec | 2024-05-14 | Warnings | M012 |
| Day Time Cold and Flu Relief non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Safeway, Inc. | cc450f89-a156-48e0-82ae-19782f13c2ca | 2024-05-13 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Safeway, Inc. | a8df5c04-0f92-4013-b3e5-2b45009a7b8d | 2024-05-13 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE | Safeway, Inc. | f762600a-f4b1-4869-a04b-8431c3d8a3e3 | 2024-05-13 | Warnings | M012 |
| Cold and Flu DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Safeway, Inc. | ef0cd436-5e81-47a7-92d6-58495283ab28 | 2024-05-13 | Warnings | M012 |
| Tussin Cough Sugar Free | DEXTROMETHORPHAN HBR GUAIFENESIN | P & L Development, LLC | 7ed2fe86-3346-4308-a9b6-6a264f879b02 | 2024-05-09 | Warnings | M012 |
| Severe Cold and Flu Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | KROGER COMPANY | 10106c90-f2f0-508e-e063-6294a90a544b | 2024-05-08 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | Kroger | 1013ce02-7b12-335e-e063-6394a90af3e6 | 2024-05-08 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | Kroger | 10b08ea8-693e-eb18-e063-6394a90af548 | 2024-05-08 | Warnings | M012 |
| Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 10b0bcff-d3bc-f70c-e063-6394a90a35ed | 2024-05-08 | Warnings | M012 |
| Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger | 10b0e0a0-b878-0a9a-e063-6394a90a20e0 | 2024-05-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | c1873a4c-661f-4896-bcc0-f6d3a655de94 | 5 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 | 5 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | c1873a4c-661f-4896-bcc0-f6d3a655de94 | 5 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 | 5 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | c1873a4c-661f-4896-bcc0-f6d3a655de94 | 5 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 | 5 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 3dbdf020-ca17-1197-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 489645ad-d7da-5f52-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 489645ad-d7da-5f52-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 3dbdf020-ca17-1197-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 489645ad-d7da-5f52-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 3dbdf020-ca17-1197-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 437e6a13-a4ff-4f98-8973-042f224ee85e | 3 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 437e6a13-a4ff-4f98-8973-042f224ee85e | 3 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 437e6a13-a4ff-4f98-8973-042f224ee85e | 3 |
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | c46e1443-dffe-47a9-bc9a-acbe3a8b0b41 | 1 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | c46e1443-dffe-47a9-bc9a-acbe3a8b0b41 | 1 |
Packages#
| 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 |