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 PediaClear 8 | PYRILAMINE MALEATE | GM Pharmaceuticals, INC | 8e524967-d01c-4c93-9198-c42f15fe3fe0 | 2025-10-03 | Warnings | M012 |
| Childrens PediaClear PD | TRIPROLIDINE HYDROCHLORIDE | GM Pharmaceuticals, INC | f3ede5b7-1b0f-493a-b647-4459affc7e54 | 2025-10-03 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | InvaTech Pharma Solutions LLC | 40288ecf-043d-eb9e-e063-6394a90ac0a7 | 2025-10-02 | Warnings | M012 |
| Guaifenesin 400 | GUAIFENESIN TABLETS 400 | InvaTech Pharma Solutions LLC | 40291505-55ca-0759-e063-6394a90acee1 | 2025-10-02 | M012 | |
| CVS Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy | 3dd5b783-5b64-24b5-e063-6394a90ab4ee | 2025-10-02 | Warnings | M012 |
| Acetaminophen and Diphenhydramine citrate | ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE | InvaTech Pharma Solutions LLC | 403a88fa-e06b-9b6e-e063-6394a90a97b8 | 2025-10-02 | Warnings | M012 |
| Equaline childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | United Natural Foods, Inc. dba UNFI | 3053f6d7-0eff-488c-8901-770dcc62af06 | 2025-10-02 | Warnings | M012 |
| Rompe Pecho CF | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Dextrum Laboratories, Inc | 401a97af-36ae-4e54-e063-6294a90ab3ee | 2025-10-01 | Warnings | M012 |
| NyQuil Severe plus Vicks VapoCool Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | The Procter & Gamble Manufacturing Company | 724d0889-5ba5-3125-e053-2a91aa0a92c1 | 2025-10-01 | Warnings | M012 |
| DayQuil Severe plus Vicks VapoCool Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | 724f2833-34bd-6a9e-e053-2991aa0a073d | 2025-10-01 | Warnings | M012 |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | InvaTech Pharma Solutions LLC | b8d360fa-0d80-f6a8-e053-2a95a90a8bd4 | 2025-10-01 | M012 | |
| LEADER TUSSIN CF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Cardinal Health 110, LLC. dba Leader | f4ffe87b-0a62-44ac-b84a-08cf77cda7f5 | 2025-10-01 | Warnings | M012 |
| Nasal Spray, 1oz, 24/7 Life by 7-Eleven | OXYMETAZOLINE HCL NASAL SOLUTION 0.05% | Lil' Drug Store Products, Inc. | 3e781417-9ffc-f2c9-e063-6294a90a7205 | 2025-09-30 | Warnings | M012 |
| Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant | MENTHOL | Lofthouse of Fleetwood, Ltd. | d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf | 2025-09-30 | Warnings | M012 |
| Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Dextrum Laboratories, Inc | 3ff240ba-90b2-4c17-e063-6394a90ac56f | 2025-09-29 | Warnings | M012 |
| Dometuss | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dextrum Laboratories, Inc | 3fcace53-a81f-e774-e063-6294a90a32fa | 2025-09-27 | Warnings | M012 |
| nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | f6a3680a-3ac6-4fd4-be52-ce29064c4aa1 | 2025-09-26 | Warnings | M012 |
| No Drip Severe Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | 9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae5 | 2025-09-26 | Warnings | M012 |
| Giltuss Allergy Plus | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3fa0b3be-2124-ed1d-e063-6294a90aaf48 | 2025-09-25 | Warnings | M012 |
| MGC Health Cough Drops Honey Herb | MENTHOL | Medical Group Care LLC | 3fa17255-514f-db47-e063-6294a90ae454 | 2025-09-25 | 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 |