Allergy Relief
- Product NDC
- 83059-0021
- 11-digit product format
- 830590021
- Labeler code
- 83059
- Product ID
- 83059-0021_458bc75f-0997-fc09-e063-6294a90a7559
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Shield Pharmaceuticals Corp
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-23
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 83059-0021-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 83059-0021-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 83059-0021-3 | a1b67e2a42f9… | c4cf2c586c0d… |
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
- Allergy Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049630 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5015a380-a229-4eff-8e31-528065c6ed64 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83059-0021-3 | Allergy Relief | 36 in 1 BOTTLE | TABLET, COATED | 36 | 9 | |
| 83059-0021-3 | Allergy Relief | 1 in 1 CARTON | TABLET, COATED | 1 | 9 |
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 |
|---|---|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 0203d919-dc1f-cca0-e063-6394a90aa1aa | 2026-04-27 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 507214ad-1e06-fe21-e063-6294a90a59cd | 2026-04-27 | Warnings | M012 |
| ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50738a43-7299-270c-e063-6294a90af2cc | 2026-04-27 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 50762d7c-5efd-4f83-e063-6294a90abf7f | 2026-04-27 | Warnings | M012 |
| Cold and Flu Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L.N.K. International, Inc. | 6427b418-89d1-4eac-b25b-0adfefc204fc | 2026-04-27 | Warnings | M012 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | Care One (American Sales Company) | bd5de3b3-7cb5-4403-b664-23ac70b9957f | 2026-04-27 | Warnings | M012 |
| Leader Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. dba Leader | 333c7042-95b8-4d98-9df1-4287017afa36 | 2026-04-25 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | Sportpharm LLC | f2d55d1b-c3d4-4c35-b761-681ed50273bd | 2026-04-24 | Warnings | M012 |
| Geri-Dryl allergy relief | DIPHENHYDRAMINE HCL | Sportpharm LLC | 2c4e0d5e-958d-4274-876a-52126c795c0f | 2026-04-24 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50364a42-3333-51fe-e063-6394a90ab71e | 2026-04-24 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5036dc50-e95b-ea8d-e063-6394a90a6cfe | 2026-04-24 | Warnings | M012 |
| Cold and Flu Daytime Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dcb33d5f-87fa-4043-9b6d-36adec96796c | 2026-04-24 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | Cardinal Health 107, LLC | abc0e348-8532-4658-bd8c-d7dbe5a28c7d | 2026-04-23 | Warnings | M012 |
| nitetime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Publix Super Markets Inc | c5535aaf-c029-48d8-97d1-105a49b5fd95 | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer Healthcare LLC. | 50228b3c-d54a-485d-e063-6394a90a4403 | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Flu Severe Fast Chewables | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5025a333-6378-bf59-e063-6394a90af4f0 | 2026-04-23 | Warnings | M012 |
| POLY-HIST DM | DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR | POLY PHARMACEUTICALS, INC. | 5025c99f-b946-e2e0-e063-6394a90a13fb | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5026611c-93e7-8f90-e063-6394a90a7baa | 2026-04-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | c9c1db0f-6ba4-433c-b0ce-e99e9351c0b0 | 2026-04-23 | Warnings | M012 |
| Severe Cold and Flu Plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | COSTCO WHOLESALE CORPORATION | 5180abbc-c6c4-4b82-b6e7-4504e3bcff0f | 2026-04-23 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 5015a380-a229-4eff-8e31-528065c6ed64 | 9 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 5015a380-a229-4eff-8e31-528065c6ed64 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83059-0021-3 | 83059002103 | 1 BOTTLE in 1 CARTON (83059-0021-3) / 36 TABLET, COATED in 1 BOTTLE | 1 bottle | 2024-01-23 | No | No | Current |